Trial Outcomes & Findings for GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL) (NCT NCT01419665)
NCT ID: NCT01419665
Last Updated: 2021-05-14
Results Overview
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
629 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-05-14
Participant Flow
A total of 629 patients were randomized at 159 centers in 26 countries, 314 patients to GP2013 (312 patients treated) and 315 to MabThera. Of those 314 patients in the GP2013 group, 2 patients were randomized by error and discontinued before any treatment with GP2013. The number of patients in both treatment groups remained similar.
full analysis set participants : GP2013 312 MabThera 315 safety set participants : GP2013 312 MabThera 315 per protocol set participants: GP2013 310 MabThera 312 pharmacokinetic analysis set 1 : GP2013 119 MabThera 120 immunogenicity analysis set: GP2013 275 MabThera 287 pharmacodynamic analysis set : GP2013 24 MabThera 24
Participant milestones
| Measure |
GP2013
Experimental Type: Biological/Vaccine
|
Rituximab
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
Combination Treatment
STARTED
|
312
|
315
|
|
Combination Treatment
COMPLETED
|
274
|
274
|
|
Combination Treatment
NOT COMPLETED
|
38
|
41
|
|
Maintenance Treatment and/or Follow up
STARTED
|
254
|
252
|
|
Maintenance Treatment and/or Follow up
COMPLETED
|
132
|
150
|
|
Maintenance Treatment and/or Follow up
NOT COMPLETED
|
122
|
102
|
|
Open Label Phase
STARTED
|
44
|
39
|
|
Open Label Phase
COMPLETED
|
43
|
38
|
|
Open Label Phase
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
GP2013
Experimental Type: Biological/Vaccine
|
Rituximab
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
Combination Treatment
Adverse Event
|
7
|
10
|
|
Combination Treatment
Physician Decision
|
5
|
8
|
|
Combination Treatment
Protocol Violation
|
6
|
2
|
|
Combination Treatment
disease progression
|
10
|
9
|
|
Combination Treatment
Death
|
5
|
7
|
|
Combination Treatment
administrative problems
|
0
|
1
|
|
Combination Treatment
Withdrawal by Subject
|
5
|
4
|
|
Maintenance Treatment and/or Follow up
switch to open label
|
44
|
39
|
|
Maintenance Treatment and/or Follow up
administrative problems
|
0
|
6
|
|
Maintenance Treatment and/or Follow up
Withdrawal by Subject
|
6
|
6
|
|
Maintenance Treatment and/or Follow up
Protocol Violation
|
1
|
1
|
|
Maintenance Treatment and/or Follow up
Physician Decision
|
5
|
2
|
|
Maintenance Treatment and/or Follow up
disease progression
|
53
|
37
|
|
Maintenance Treatment and/or Follow up
Death
|
1
|
2
|
|
Maintenance Treatment and/or Follow up
Adverse Event
|
11
|
7
|
|
Maintenance Treatment and/or Follow up
Lost to Follow-up
|
1
|
2
|
|
Open Label Phase
Death
|
1
|
0
|
|
Open Label Phase
disease progression
|
0
|
1
|
Baseline Characteristics
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Baseline characteristics by cohort
| Measure |
GP2013
n=312 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=315 Participants
Comparator Type: Biological/Vaccine
|
Total
n=627 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 11.72 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
71 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
214 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
183 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
59 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian (Indian Subcontinent)
|
40 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Ethnicity
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown / missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: per protocol set, participants with measure
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
Outcome measures
| Measure |
GP2013
n=311 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=313 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
Overall Response Rate (ORR)
|
87.1 percentage
Interval 83.59 to 90.15
|
87.5 percentage
Interval 84.04 to 90.49
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: per protocol set, participants with measure
Outcome measures
| Measure |
GP2013
n=311 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=313 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
|
46 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: per protocol set, participants with measure
Outcome measures
| Measure |
GP2013
n=311 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=313 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
|
225 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: per protocol set, participants with measure
Number of participants with progression free survival events
Outcome measures
| Measure |
GP2013
n=312 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=315 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
|
97 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: per protocol set, participants with measure
OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.
Outcome measures
| Measure |
GP2013
n=312 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=315 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
|
29 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 24 weeks, 3 yearsPopulation: immunogenicity set, participants with measure
number of participants with confirmed positive ADA
Outcome measures
| Measure |
GP2013
n=275 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=287 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
end of treatment combination phase (24 weeks)
|
1 Participants
|
2 Participants
|
|
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
end of treatment manintenance phase (3 years)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 63Population: pharmacokinetic analysis set 1, participants with measure
C max For descriptive purposes only, no hypothesis testing
Outcome measures
| Measure |
GP2013
n=119 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=120 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
|
333.59 microg/mL
Geometric Coefficient of Variation 41.09
|
331.93 microg/mL
Geometric Coefficient of Variation 35.32
|
SECONDARY outcome
Timeframe: day 63Population: pharmacokinetic analysis set 1, participants with measure
C through For descriptive purposes only, no hypothesis testing
Outcome measures
| Measure |
GP2013
n=119 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=120 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
|
66.42 microg/mL
Standard Deviation 47.593
|
82.13 microg/mL
Standard Deviation 61.526
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Pharmnacodynamic analysis set, participants with measure
AUEC (0-21d) For descriptive purposes only, no hypothesis testing
Outcome measures
| Measure |
GP2013
n=24 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=24 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
|
1790 %*day
Geometric Coefficient of Variation 23.5
|
1910 %*day
Geometric Coefficient of Variation 13.3
|
POST_HOC outcome
Timeframe: 30 months, 3 yearsPopulation: clinical data base population - treated patients
On treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days) Deaths post treatment survival follow up were collected after the on- treatment period, up to 3 years.
Outcome measures
| Measure |
GP2013
n=312 Participants
Experimental Type: Biological/Vaccine
|
Rituximab
n=315 Participants
Comparator Type: Biological/Vaccine
|
|---|---|---|
|
All Collected Deaths
on treatment death
|
4 Participants
|
5 Participants
|
|
All Collected Deaths
on treatment deaths maintenance
|
2 Participants
|
2 Participants
|
|
All Collected Deaths
all deaths
|
29 Participants
|
31 Participants
|
Adverse Events
Combination GP2013+CVP
Serious events: 71 serious events
Other events: 262 other events
Deaths: 4 deaths
Combination MabThera+CVP
Serious events: 63 serious events
Other events: 255 other events
Deaths: 5 deaths
Maintenance GP2013
Serious events: 24 serious events
Other events: 141 other events
Deaths: 2 deaths
Maintenance MabThera
Serious events: 21 serious events
Other events: 144 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Combination GP2013+CVP
n=312 participants at risk
Combination GP2013+CVP
|
Combination MabThera+CVP
n=315 participants at risk
Combination MabThera+CVP
|
Maintenance GP2013
n=254 participants at risk
Maintenance GP2013
|
Maintenance MabThera
n=252 participants at risk
Maintenance MabThera
|
|---|---|---|---|---|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.63%
2/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
15/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.9%
9/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.64%
2/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.63%
2/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
4/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
5/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.64%
2/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Extrasystoles
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Palpitations
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Prinzmetal angina
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Cardiac disorders
Tachycardia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Congenital, familial and genetic disorders
Polycystic liver disease
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Eye disorders
Cataract
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
4/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.9%
6/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Ascites
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Colitis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Constipation
|
0.96%
3/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.95%
3/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.95%
3/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.63%
2/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Asthenia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Chills
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Fatigue
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Hypothermia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Malaise
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.63%
2/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Non-cardiac chest pain
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Oedema peripheral
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Pain
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Pyrexia
|
1.3%
4/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.2%
7/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Sudden death
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.63%
2/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Abscess limb
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Bronchitis
|
0.64%
2/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Cholecystitis infective
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Cystitis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Endometritis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Helicobacter infection
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Herpes zoster
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Influenza
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Malaria
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Oral candidiasis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Pneumonia
|
0.96%
3/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.3%
4/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.2%
3/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Pyelonephritis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Sepsis
|
0.64%
2/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
5/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Septic shock
|
0.96%
3/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Urinary tract infection
|
0.96%
3/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Viral infection
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.96%
3/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Investigations
Alanine aminotransferase increased
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Investigations
Aspartate aminotransferase increased
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Investigations
Coagulation test abnormal
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Investigations
Lipase increased
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Investigations
Weight decreased
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.64%
2/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.63%
2/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Dementia
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Dizziness
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Headache
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Hemiparesis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Meningeal disorder
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Syncope
|
0.64%
2/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Psychiatric disorders
Confusional state
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Psychiatric disorders
Delirium
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Psychiatric disorders
Depression
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Psychiatric disorders
Mental disorder
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Anuria
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Oliguria
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Pollakiuria
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Renal colic
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Renal failure
|
0.64%
2/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Reproductive system and breast disorders
Prostatism
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.9%
6/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.95%
3/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.95%
3/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Vascular disorders
Deep vein thrombosis
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Vascular disorders
Hypotension
|
0.32%
1/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.32%
1/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.00%
0/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
Other adverse events
| Measure |
Combination GP2013+CVP
n=312 participants at risk
Combination GP2013+CVP
|
Combination MabThera+CVP
n=315 participants at risk
Combination MabThera+CVP
|
Maintenance GP2013
n=254 participants at risk
Maintenance GP2013
|
Maintenance MabThera
n=252 participants at risk
Maintenance MabThera
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
25/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
8.9%
28/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.4%
23/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.9%
25/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.3%
11/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
78/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
28.9%
91/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
12.6%
32/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
6.3%
16/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.0%
28/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
11.1%
35/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.4%
6/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.8%
7/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.4%
20/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.1%
16/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.8%
7/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Constipation
|
22.1%
69/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
20.3%
64/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.1%
8/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.0%
10/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
39/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
10.5%
33/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.3%
11/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.1%
18/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Nausea
|
16.3%
51/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
13.3%
42/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.3%
11/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.2%
8/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
22/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
8.3%
26/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.4%
6/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.8%
12/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Asthenia
|
9.6%
30/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
9.8%
31/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.7%
12/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.4%
11/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Fatigue
|
11.2%
35/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
9.8%
31/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.4%
6/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.0%
10/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Oedema peripheral
|
4.2%
13/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.6%
24/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.4%
11/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
General disorders
Pyrexia
|
8.7%
27/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
10.2%
32/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.7%
12/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.2%
13/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Influenza
|
5.1%
16/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.2%
7/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.8%
7/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.2%
8/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
22/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.0%
22/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.7%
12/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
6.7%
17/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Urinary tract infection
|
8.7%
27/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.0%
22/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.5%
14/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
9.9%
25/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.6%
8/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.2%
10/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
6.0%
15/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
13.1%
41/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
11.7%
37/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.4%
17/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
6.7%
21/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.2%
3/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
17/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.0%
22/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.6%
9/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.6%
8/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.7%
18/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.0%
10/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
19/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
6.7%
21/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.5%
9/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
8.3%
21/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
26/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
9.5%
30/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.5%
14/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.6%
14/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
17/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
6.3%
20/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.2%
3/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
19/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.6%
24/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.8%
7/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.6%
14/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Dizziness
|
5.8%
18/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.8%
12/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Headache
|
9.3%
29/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
10.8%
34/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.7%
12/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.6%
14/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Neuropathy peripheral
|
15.7%
49/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
9.5%
30/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
3.1%
8/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.79%
2/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Paraesthesia
|
7.7%
24/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
14.0%
44/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.8%
7/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
26/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
7.3%
23/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.4%
6/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Psychiatric disorders
Insomnia
|
4.8%
15/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
6.0%
19/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.2%
3/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
32/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
11.7%
37/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
13.0%
33/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
9.1%
23/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
16/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
5.4%
17/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
2.0%
5/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
1.6%
4/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.9%
31/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
8.3%
26/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.39%
1/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
0.40%
1/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
|
Vascular disorders
Hypertension
|
7.1%
22/312 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.8%
15/315 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.7%
12/254 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
4.8%
12/252 • On treatment AE, SAE and deaths were collected from the start of treatment up to 30/90 days after study drug discontinuation (30 days for combination phase and 90 for maintenance/open label phase), for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days)
Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER