Trial Outcomes & Findings for Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML (NCT NCT01883362)
NCT ID: NCT01883362
Last Updated: 2021-03-17
Results Overview
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
date of transplant up to 18 months
Results posted on
2021-03-17
Participant Flow
Participant milestones
| Measure |
Standard of Care With Midostaurin
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
Patients received standard of care alone in the post SCT setting
|
|---|---|---|
|
Treatment
STARTED
|
30
|
30
|
|
Treatment
COMPLETED
|
14
|
16
|
|
Treatment
NOT COMPLETED
|
16
|
14
|
|
Post Treatment Follow-up
STARTED
|
26
|
27
|
|
Post Treatment Follow-up
COMPLETED
|
10
|
13
|
|
Post Treatment Follow-up
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
Standard of Care With Midostaurin
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
Patients received standard of care alone in the post SCT setting
|
|---|---|---|
|
Treatment
Adverse Event
|
1
|
8
|
|
Treatment
Withdrawal by Subject
|
6
|
2
|
|
Treatment
Administrative problems
|
4
|
1
|
|
Treatment
Relapse
|
4
|
2
|
|
Treatment
Randomized, not treated
|
1
|
1
|
|
Post Treatment Follow-up
Protocol Violation
|
0
|
1
|
|
Post Treatment Follow-up
Withdrawal by Subject
|
4
|
3
|
|
Post Treatment Follow-up
Lost to Follow-up
|
1
|
4
|
|
Post Treatment Follow-up
Administrative problems
|
2
|
0
|
|
Post Treatment Follow-up
Death
|
8
|
4
|
|
Post Treatment Follow-up
Relapse
|
1
|
2
|
Baseline Characteristics
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
Baseline characteristics by cohort
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 13.68 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 11.08 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 12.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Body Mass Index
|
26.9934 kg/m^2
STANDARD_DEVIATION 7.11368 • n=5 Participants
|
26.6400 kg/m^2
STANDARD_DEVIATION 5.27475 • n=7 Participants
|
26.8101 kg/m^2
STANDARD_DEVIATION 6.17055 • n=5 Participants
|
PRIMARY outcome
Timeframe: date of transplant up to 18 monthsRelapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis
6 months
|
0.93 proportion of participants
Interval 0.75 to 0.98
|
0.93 proportion of participants
Interval 0.74 to 0.98
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis
12 months
|
0.80 proportion of participants
Interval 0.59 to 0.91
|
0.93 proportion of participants
Interval 0.74 to 0.98
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis
18 months
|
0.76 proportion of participants
Interval 0.54 to 0.88
|
0.89 proportion of participants
Interval 0.69 to 0.96
|
—
|
SECONDARY outcome
Timeframe: Randomization to 18 monthsRelapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
6 months
|
0.93 Proportion of participants
Interval 0.75 to 0.98
|
0.93 Proportion of participants
Interval 0.74 to 0.98
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
12 months
|
0.80 Proportion of participants
Interval 0.59 to 0.91
|
0.93 Proportion of participants
Interval 0.74 to 0.98
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
18 months
|
0.76 Proportion of participants
Interval 0.54 to 0.88
|
0.85 Proportion of participants
Interval 0.64 to 0.94
|
—
|
SECONDARY outcome
Timeframe: date of transplant up to 24 monthsDFS was defined as the time from transplant to relapse or death due to any cause. If a patient had more than 1 event (e.g., relapse then death) then the earliest date was taken into account.
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
6 months
|
0.90 Proportion of participants
Interval 0.71 to 0.96
|
0.93 Proportion of participants
Interval 0.74 to 0.98
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
12 months
|
0.77 Proportion of participants
Interval 0.56 to 0.89
|
0.89 Proportion of participants
Interval 0.7 to 0.96
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
18 months
|
0.69 Proportion of participants
Interval 0.48 to 0.83
|
0.85 Proportion of participants
Interval 0.65 to 0.94
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
24 months
|
0.69 Proportion of participants
Interval 0.48 to 0.83
|
0.81 Proportion of participants
Interval 0.61 to 0.92
|
—
|
SECONDARY outcome
Timeframe: date of transplant up to 24 monthsRelapse-free survival was defined as the time from transplant to relapse or death due to the disease 24 months post-transplant. If a patient had more than one event (e.g., relapse then death) then the earliest date was taken into account.
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
6 months
|
0.93 Proportion of participants
Interval 0.75 to 0.98
|
0.93 Proportion of participants
Interval 0.74 to 0.98
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
12 months
|
0.80 Proportion of participants
Interval 0.59 to 0.91
|
0.93 Proportion of participants
Interval 0.74 to 0.98
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
18 months
|
0.76 Proportion of participants
Interval 0.54 to 0.88
|
0.89 Proportion of participants
Interval 0.69 to 0.96
|
—
|
|
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
24 months
|
0.76 Proportion of participants
Interval 0.54 to 0.88
|
0.85 Proportion of participants
Interval 0.64 to 0.94
|
—
|
SECONDARY outcome
Timeframe: date of transplant up to 24 monthsOverall survival was defined as the time from transplant to death due to any cause.
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
6 months
|
0.96 proportion of participants
Interval 0.71 to 0.96
|
1.00 proportion of participants
Interval 1.0 to 1.0
|
—
|
|
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
12 months
|
0.89 proportion of participants
Interval 0.56 to 0.89
|
0.89 proportion of participants
Interval 0.69 to 0.96
|
—
|
|
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
18 months
|
0.76 proportion of participants
Interval 0.54 to 0.89
|
0.85 proportion of participants
Interval 0.65 to 0.94
|
—
|
|
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
24 months
|
0.76 proportion of participants
Interval 0.54 to 0.89
|
0.85 proportion of participants
Interval 0.65 to 0.94
|
—
|
SECONDARY outcome
Timeframe: date of transplant up to 24 monthsNon-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
6 months
|
0.96 proportion of participants
Interval 0.77 to 0.99
|
1.00 proportion of participants
Interval 1.0 to 1.0
|
—
|
|
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
12 months
|
0.96 proportion of participants
Interval 0.77 to 0.99
|
0.96 proportion of participants
Interval 0.76 to 0.99
|
—
|
|
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
18 months
|
0.92 proportion of participants
Interval 0.71 to 0.98
|
0.96 proportion of participants
Interval 0.76 to 0.99
|
—
|
|
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
24 months
|
0.92 proportion of participants
Interval 0.71 to 0.98
|
0.96 proportion of participants
Interval 0.76 to 0.99
|
—
|
SECONDARY outcome
Timeframe: up to 24 months from date of transplannt or at study completionPopulation: Insufficient amount of samples to perform analysis
Unable to retrieve a sufficient amount of archived samples to perform an analysis therefore the study was not able to verify the FLT3-ITD mutation status
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on days 1 and 15 of Cycle 1, on day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12Population: number of samples available differed across time points
Pre-dose levels (Cmin) will be directly determined from raw plasma concentration-time data. Values below the lower limit of quantification (LLOQ) will be treated as zero in any calculations of summary statistics.
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=29 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=29 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
n=29 Participants
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 2,Cycle1,Day 1
|
17.46 ng/ml
Standard Deviation 76.806
|
0.00 ng/ml
Standard Deviation 0.000
|
16.89 ng/ml
Standard Deviation 61.212
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 4,Cycle1, Day 15
|
932.46 ng/ml
Standard Deviation 770.597
|
1572.69 ng/ml
Standard Deviation 684.955
|
906.57 ng/ml
Standard Deviation 747.836
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 5,Cycle2,Day 1
|
769.92 ng/ml
Standard Deviation 485.353
|
1768.77 ng/ml
Standard Deviation 849.580
|
779.90 ng/ml
Standard Deviation 400.244
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 6,Cycle3,Day 1
|
907.20 ng/ml
Standard Deviation 528.017
|
2051.55 ng/ml
Standard Deviation 765.758
|
929.45 ng/ml
Standard Deviation 311.841
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 7,Cycle4,Day 1
|
548.45 ng/ml
Standard Deviation 459.294
|
1707.15 ng/ml
Standard Deviation 810.143
|
714.00 ng/ml
Standard Deviation 610.925
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 8,Cycle5,Day 1
|
525.73 ng/ml
Standard Deviation 255.032
|
1742.85 ng/ml
Standard Deviation 658.905
|
722.00 ng/ml
Standard Deviation 320.977
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 9,Cycle6,Day 1
|
519.10 ng/ml
Standard Deviation 328.032
|
1757.86 ng/ml
Standard Deviation 685.740
|
763.86 ng/ml
Standard Deviation 408.290
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 10,Cycle 7 Day 1
|
754.95 ng/ml
Standard Deviation 497.976
|
1717.35 ng/ml
Standard Deviation 720.259
|
780.65 ng/ml
Standard Deviation 424.200
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 11,Cycle 8 Day 1
|
537.95 ng/ml
Standard Deviation 229.529
|
1787.21 ng/ml
Standard Deviation 733.162
|
774.84 ng/ml
Standard Deviation 326.583
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 12,Cycle 9 Day 1
|
571.76 ng/ml
Standard Deviation 311.764
|
1889.76 ng/ml
Standard Deviation 678.435
|
850.47 ng/ml
Standard Deviation 328.411
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 13,Cycle 10 Day 1
|
643.07 ng/ml
Standard Deviation 452.268
|
1836.50 ng/ml
Standard Deviation 632.894
|
851.38 ng/ml
Standard Deviation 347.311
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 14,Cycle 11 Day 1
|
718.22 ng/ml
Standard Deviation 538.208
|
1857.33 ng/ml
Standard Deviation 868.406
|
983.94 ng/ml
Standard Deviation 801.361
|
|
Plasma Pharmacokinetics (PK) of Midostaurin and the Metabolites: CGP62221 and CGP52421: Pre-dose Levels
Visit 15,Cycle 12 Day 1
|
564.69 ng/ml
Standard Deviation 410.156
|
1706.29 ng/ml
Standard Deviation 643.326
|
763.60 ng/ml
Standard Deviation 387.685
|
POST_HOC outcome
Timeframe: approx. 12.5 months, approx. 51 monthsPopulation: Clinical Database Population: all treated patients
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months). Deaths post treatment survival follow up were collected after the on treatment period, up to approximately 51 months.
Outcome measures
| Measure |
Standard of Care With Midostaurin
n=30 Participants
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 Participants
Patients received standard of care alone in the post SCT setting
|
Metabolite CGP62221
Metabolite of PKC412 (CGP62221)
|
|---|---|---|---|
|
All Collected Deaths
Total Deaths
|
8 Participants
|
4 Participants
|
—
|
|
All Collected Deaths
Deaths on-treatment
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
Standard of Care With Midostaurin
Serious events: 9 serious events
Other events: 28 other events
Deaths: 1 deaths
Standard of Care
Serious events: 15 serious events
Other events: 26 other events
Deaths: 0 deaths
ALL Patients
Serious events: 24 serious events
Other events: 54 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard of Care With Midostaurin
n=30 participants at risk
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 participants at risk
Patients received standard of care alone in the post SCT setting
|
ALL Patients
n=60 participants at risk
ALL Patients combined
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chills
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Chronic graft versus host disease in intestine
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Chronic graft versus host disease in liver
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Appendicitis
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Device related infection
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Encephalitis
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Mycobacterium fortuitum infection
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Nocardiosis
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Parainfluenzae virus infection
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pulmonary mycosis
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Amylase increased
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Lipase increased
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Platelet count decreased
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Transaminases increased
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
White blood cell count decreased
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Psychogenic seizure
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.7%
1/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
Standard of Care With Midostaurin
n=30 participants at risk
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
|
Standard of Care
n=30 participants at risk
Patients received standard of care alone in the post SCT setting
|
ALL Patients
n=60 participants at risk
ALL Patients combined
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.3%
11/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
10/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Eosinophilia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Tachycardia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Endocrine disorders
Cushingoid
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Dry eye
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
10/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Lacrimation increased
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Vision blurred
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.7%
7/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
9/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.7%
13/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.0%
9/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
63.3%
19/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
40.0%
24/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
20/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
41.7%
25/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Asthenia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Catheter site pain
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chest discomfort
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chest pain
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chills
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
23.3%
7/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.3%
7/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.3%
14/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Malaise
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Mucosal inflammation
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Oedema peripheral
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
33.3%
10/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
26.7%
16/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pain
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.7%
7/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Graft versus host disease
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Graft versus host disease in eye
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Graft versus host disease in skin
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Folliculitis
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Influenza
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Rhinovirus infection
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.0%
9/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.3%
7/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
12/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
8/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood bilirubin increased
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood creatinine increased
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Lipase increased
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
23.3%
7/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
10/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Platelet count decreased
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.7%
7/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Transaminases increased
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Weight decreased
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
White blood cell count decreased
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
8/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
8/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.7%
7/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.0%
9/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.0%
9/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness postural
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dysgeusia
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Headache
|
26.7%
8/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
21.7%
13/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hyperaesthesia
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Neuropathy peripheral
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Tremor
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
8/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
10/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Renal failure
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.7%
8/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
23.3%
14/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
15.0%
9/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
4/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
3/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
5/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Melanocytic naevus
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
2/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
10/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
5/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
18.3%
11/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
13.3%
4/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
10.0%
6/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
20.0%
6/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.3%
8/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.7%
2/30 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.0%
3/60 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
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