Trial Outcomes & Findings for Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC) (NCT NCT02435680)
NCT ID: NCT02435680
Last Updated: 2021-06-21
Results Overview
PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
4 years
Results posted on
2021-06-21
Participant Flow
In total, 50 subjects were enrolled into the study and 49 subjects received study treatment.
Participant milestones
| Measure |
MCS110+Carboplatin+Gemcitabine
experimental. MCS110 10mg/kg intravenous infusion on day 1.
|
MCS110 With C1D8 Dose+Carboplatin+Gemcitabine
experimental.MCS110 10mg/kg intravenous infusion on day 1 and day 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
13
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
13
|
16
|
Reasons for withdrawal
| Measure |
MCS110+Carboplatin+Gemcitabine
experimental. MCS110 10mg/kg intravenous infusion on day 1.
|
MCS110 With C1D8 Dose+Carboplatin+Gemcitabine
experimental.MCS110 10mg/kg intravenous infusion on day 1 and day 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
|
Overall Study
subject / guardian decision
|
0
|
3
|
2
|
|
Overall Study
Adverse Event
|
8
|
3
|
2
|
|
Overall Study
progressive disease
|
10
|
7
|
11
|
|
Overall Study
not treated
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)
Baseline characteristics by cohort
| Measure |
MCS110+Carboplatin+Gemcitabine
n=21 Participants
experimental. MCS110 10mg/kg intravenous infusion on day 1.
|
MCS110 With C1D8 Dose + Carboplatin +Gemcitabine
n=13 Participants
experimental.MCS110 10mg/kg intravenous infusion on days 1 \& 8
|
Carboplatin+Gemcitabine
n=16 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 12.97 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 12.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: full analysis set: all MCS110 treated patients versus comparator
PFS Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=34 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=16 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Progression Free Survival (PFS) as Per RECIST v1.1 (by Local Investigator Assessment)
|
5.6 months
Interval 4.5 to 8.7
|
5.5 months
Interval 3.5 to 7.5
|
—
|
SECONDARY outcome
Timeframe: day 21 (end cycle 1); day 84 (end cycle 4)Population: pharmacokinetic analysis set
AUC tau derived from day 0 to 21 (cycle 1) from day 0 to 21 (cycle 4) Cycle duration is 21 days
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau
day 21
|
1430 day * microgram / mL
Geometric Coefficient of Variation 23.5
|
2960 day * microgram / mL
Geometric Coefficient of Variation 22.7
|
—
|
|
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: AUCtau
day 84
|
1840 day * microgram / mL
Geometric Coefficient of Variation 34.9
|
3240 day * microgram / mL
Geometric Coefficient of Variation 30.0
|
—
|
SECONDARY outcome
Timeframe: day 21 (end cycle 1); day 84 (end cycle 4)Population: pharmacokinetic analysis set
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax
day 21
|
186 microgram / mL
Geometric Coefficient of Variation 28.5
|
281 microgram / mL
Geometric Coefficient of Variation 21.2
|
—
|
|
Free MCS110 : Derived Pharmacokinetics (PK) Parameters: Cmax
day 84
|
240 microgram / mL
Geometric Coefficient of Variation 14.8
|
319 microgram / mL
Geometric Coefficient of Variation 27.8
|
—
|
SECONDARY outcome
Timeframe: day 21, day 84Population: pharmacokinetic analysis set
day 21 (end cycle 1); day 84 (end cycle 4)
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Cmax Carboplatin Day 21
|
12400 nanogram /mL
Geometric Coefficient of Variation 37.3
|
12500 nanogram /mL
Geometric Coefficient of Variation 33.2
|
11200 nanogram /mL
Geometric Coefficient of Variation 70.9
|
|
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Cmax Carboplatin Day 84
|
9550 nanogram /mL
Geometric Coefficient of Variation 33.0
|
10000 nanogram /mL
Geometric Coefficient of Variation 28.9
|
11600 nanogram /mL
Geometric Coefficient of Variation 55.0
|
|
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Cmax Gemcitabine Day 21
|
2750 nanogram /mL
Geometric Coefficient of Variation 194.5
|
5480 nanogram /mL
Geometric Coefficient of Variation 95.1
|
2370 nanogram /mL
Geometric Coefficient of Variation 484.9
|
|
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Cmax Gemcitabine Day 84
|
2470 nanogram /mL
Geometric Coefficient of Variation 227.3
|
3400 nanogram /mL
Geometric Coefficient of Variation 173.9
|
8630 nanogram /mL
Geometric Coefficient of Variation 101.2
|
|
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Cmax dFdU Day 21
|
39100 nanogram /mL
Geometric Coefficient of Variation 21.6
|
33900 nanogram /mL
Geometric Coefficient of Variation 19.5
|
37700 nanogram /mL
Geometric Coefficient of Variation 28.2
|
|
Cmax Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
Cmax dFdU Day 84
|
36600 nanogram /mL
Geometric Coefficient of Variation 88.6
|
30300 nanogram /mL
Geometric Coefficient of Variation 11.8
|
32300 nanogram /mL
Geometric Coefficient of Variation 12.4
|
SECONDARY outcome
Timeframe: day 21, day 84Population: pharmacokinetic analysis set
day 21 (end cycle 1); day 84 (end cycle 4)
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
AUC Carboplatin Day 21
|
24500 hours * nanogram /mL
Geometric Coefficient of Variation 31.1
|
21400 hours * nanogram /mL
Geometric Coefficient of Variation 27.3
|
21800 hours * nanogram /mL
Geometric Coefficient of Variation 56.0
|
|
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
AUC Carboplatin Day 84
|
18300 hours * nanogram /mL
Geometric Coefficient of Variation 21.8
|
17500 hours * nanogram /mL
Geometric Coefficient of Variation 25.0
|
20500 hours * nanogram /mL
Geometric Coefficient of Variation 34.6
|
|
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
AUC Gemcitabine Day 21
|
2390 hours * nanogram /mL
Geometric Coefficient of Variation 157.3
|
4270 hours * nanogram /mL
Geometric Coefficient of Variation 79.3
|
2620 hours * nanogram /mL
Geometric Coefficient of Variation 225.5
|
|
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
AUC Gemcitabine Day 84
|
2410 hours * nanogram /mL
Geometric Coefficient of Variation 115.2
|
2770 hours * nanogram /mL
Geometric Coefficient of Variation 118.8
|
6320 hours * nanogram /mL
Geometric Coefficient of Variation 76.2
|
|
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
AUC dFdU Day 21
|
230000 hours * nanogram /mL
Geometric Coefficient of Variation 34.7
|
181000 hours * nanogram /mL
Geometric Coefficient of Variation 37.7
|
231000 hours * nanogram /mL
Geometric Coefficient of Variation 25.2
|
|
AUClast Derived From Plasma Concentration of Carboplatin, Gemcitabine and 2',2'-Difluoro-deoxyuridine (dFdU)
AUC dFdU Day 84
|
229000 hours * nanogram /mL
Geometric Coefficient of Variation 31.9
|
147000 hours * nanogram /mL
Geometric Coefficient of Variation 28.7
|
211000 hours * nanogram /mL
Geometric Coefficient of Variation 24.7
|
SECONDARY outcome
Timeframe: baseline, day 1, 4, 15, 22, 43, 64, 85, 106, 127, 148Population: Safety set - MCS110 treated patients only
results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days. These Biomarker Analyses were performed for MCS110 treated patients only.
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 1
|
110 % change from baseline
Standard Deviation 19.8
|
115 % change from baseline
Standard Deviation 34.8
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 4
|
4930 % change from baseline
Standard Deviation 2280
|
4350 % change from baseline
Standard Deviation 1620
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 15
|
21600 % change from baseline
Standard Deviation 8290
|
19500 % change from baseline
Standard Deviation 6130
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 22 (cycle 2 day 1)
|
32000 % change from baseline
Standard Deviation 9190
|
34400 % change from baseline
Standard Deviation 14900
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 43 (cycle 3 day 1)
|
57900 % change from baseline
Standard Deviation 14100
|
70000 % change from baseline
Standard Deviation 27400
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 64 (cycle 4 day 1)
|
73600 % change from baseline
Standard Deviation 16200
|
78000 % change from baseline
Standard Deviation 41200
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 85 (cycle 5 day 1)
|
79300 % change from baseline
Standard Deviation 27000
|
107000 % change from baseline
Standard Deviation 51400
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 106 (cycle 6 day 1)
|
97500 % change from baseline
Standard Deviation 15600
|
103000 % change from baseline
Standard Deviation 50700
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 127 (cycle 7 day 1)
|
110000 % change from baseline
Standard Deviation 33800
|
109000 % change from baseline
Standard Deviation 40100
|
—
|
|
Total Colony Stimulation Factor -1 (CSF-I) Circulating Levels
Day 148 (cycle 8 day 1)
|
108000 % change from baseline
Standard Deviation 30300
|
111000 % change from baseline
Standard Deviation 58800
|
—
|
SECONDARY outcome
Timeframe: baseline, day 2, 4, 15, 22, 43, 64, 85, 106, 127, 148Population: Safety set - MCS110 treated patients only
results expressed as a the ratio change from baseline expressed in percentage. Cycle duration is 21 days. Biomarker Analyses performed for MCS110 treated patients only.
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 2
|
79.4 % change from baseline
Standard Deviation 22.8
|
85.0 % change from baseline
Standard Deviation 44.0
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 4
|
72.5 % change from baseline
Standard Deviation 25.4
|
80.2 % change from baseline
Standard Deviation 39.6
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 15
|
65.6 % change from baseline
Standard Deviation 44.3
|
69.4 % change from baseline
Standard Deviation 27.4
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 22 (cycle 2 day 1)
|
67.9 % change from baseline
Standard Deviation 43.6
|
52.9 % change from baseline
Standard Deviation 26.5
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 43 (cycle 3 day 1)
|
64.3 % change from baseline
Standard Deviation 58.7
|
39.3 % change from baseline
Standard Deviation 23.8
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 64 (cycle 4 day 1)
|
69.7 % change from baseline
Standard Deviation 62.2
|
29.5 % change from baseline
Standard Deviation 23.7
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 85 (cycle 5 day 1)
|
102 % change from baseline
Standard Deviation 124
|
40.6 % change from baseline
Standard Deviation 34.8
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 106 (cycle 6 day 1)
|
41.2 % change from baseline
Standard Deviation 13.2
|
50.2 % change from baseline
Standard Deviation 45.3
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 127 (cycle 7 day 1)
|
38.7 % change from baseline
Standard Deviation 14.9
|
68.7 % change from baseline
Standard Deviation 66.5
|
—
|
|
Serum C-terminal Telopeptide of Type I Collagen (CTX-I)
Day 148 (cycle 8 day 1)
|
40.5 % change from baseline
Standard Deviation 13.7
|
75.3 % change from baseline
Standard Deviation 103
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: full analysis set: all MCS110 treated patients versus comparator
CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=34 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=16 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
PR
|
8 Participants
|
6 Participants
|
—
|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
Non-CR/ Non-progressive disease
|
1 Participants
|
0 Participants
|
—
|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
SD
|
19 Participants
|
7 Participants
|
—
|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
progressive disease
|
4 Participants
|
1 Participants
|
—
|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
unknown
|
2 Participants
|
2 Participants
|
—
|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
clinical benefit rate
|
10 Participants
|
7 Participants
|
—
|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment)
ORR
|
8 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: full analysis set: all MCS110 treated patients versus comparator
CR: complete response. PR: partial response. SD: stable disease: CBR: clinical benefit rate =CR + PR + SD lasting at least for 6 months. ORR = CR + PR. Efficacy Results presented for all MCS110 treated patients (with and without day 8 dose), in line with phase 2 study design.
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=34 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=16 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Tumor Response Per RECIST v1.1 (by Local Investigator Assessment) Duration of Response
|
9.6 months
Interval 3.6 to 42.5
|
5 months
Interval 2.7 to 13.3
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Safety set - MCS110 treated patients only
patients treated with MCS110 only
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption
MCS110 dose reduction
|
3 Participants
|
5 Participants
|
—
|
|
Number of Patients With at Least One MCS110 Dose Reduction, and Number of Patients With at Least One MCS110 Dose Interruption
MCS110 dose interruption
|
6 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Safety set - MCS110 treated patients only
Relative dose intensity by categories. Patients treated with MCS110 only. The dose intensity measures the dose actually taken versus the planned dose, and is expressed in percentage: \<50%: less than 50 % of the planned dose received; 50-\<75 %: dose received is 50% or more, but less than 75 %; 75-\<90 %: dose received is 75% or more, but less than 90%; 90-\<110 %: dose received is 90% or more, but less than 110%
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
MCS110 Dose Intensity
<50%
|
1 Participants
|
4 Participants
|
—
|
|
MCS110 Dose Intensity
50-<75%
|
8 Participants
|
3 Participants
|
—
|
|
MCS110 Dose Intensity
75-<90%
|
7 Participants
|
5 Participants
|
—
|
|
MCS110 Dose Intensity
90-<110%
|
3 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 29-43Population: Safety set - MCS110 treated patients only
results expressed as a the ratio change from baseline expressed in percentage: Biopsies were taken at baseline and between Day 29 and Day 43. Patients treated with MCS110 only
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=19 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
n=15 Participants
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.
CD163
|
42.1 % change from baseline
Geometric Coefficient of Variation 62.1
|
43.5 % change from baseline
Geometric Coefficient of Variation 239.5
|
—
|
|
Tumor Associated Macrophage (TAM) and Tumor Infiltrating Lymphocyte (TIL) Content in Pre- and Post-dose Tumor Biopsies.
CD8
|
102 % change from baseline
Geometric Coefficient of Variation 747.3
|
99.0 % change from baseline
Geometric Coefficient of Variation 92.2
|
—
|
SECONDARY outcome
Timeframe: day 15, 29, 43, 50Population: safety set: only 1 patient with data collected
Cycle duration is 21 days results expressed in percentage of cells. Only 1 arm reported as results were available for 1 patient only.
Outcome measures
| Measure |
All MCS110+Carboplatin+Gemcitabine
n=1 Participants
experimental. all MCS110 treated patients, with 10mg/kg intravenous infusion, on day 1 and days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
Carboplatin+Gemcitabine
comparator. Gemcitabine: Intravenous infusion 1000 mg/m2 Days 1 \& 8 Carboplatin: Intravenous infusion AUC 2 Days 1 \& 8
|
|---|---|---|---|
|
Circulating Monocytes Cells in Blood
day 15 CD14+CD16-
|
43.5 percentage
|
—
|
—
|
|
Circulating Monocytes Cells in Blood
day 15 CD14+CD16+
|
54.8 percentage
|
—
|
—
|
|
Circulating Monocytes Cells in Blood
day 29 (cycle 2 day 8) CD14+CD16-
|
86.6 percentage
|
—
|
—
|
|
Circulating Monocytes Cells in Blood
day 29 (cycle 2 day 8) CD14+CD16+
|
12.2 percentage
|
—
|
—
|
|
Circulating Monocytes Cells in Blood
day 43 (cycle 3 day 1) CD14+CD16-
|
9.1 percentage
|
—
|
—
|
|
Circulating Monocytes Cells in Blood
day 43 (cycle 3 day 1) CD14+CD16+
|
89.7 percentage
|
—
|
—
|
|
Circulating Monocytes Cells in Blood
day 50 (cycle 3 day 8) CD14+CD16-
|
86 percentage
|
—
|
—
|
|
Circulating Monocytes Cells in Blood
day 50 (cycle 3 day 8) CD14+CD16+
|
10 percentage
|
—
|
—
|
Adverse Events
MCS110 + Carbo/Gem
Serious events: 10 serious events
Other events: 19 other events
Deaths: 1 deaths
MCS110 With C1D8@Dose + Carbo/Gem
Serious events: 7 serious events
Other events: 15 other events
Deaths: 1 deaths
All MCS110 + @Carbo/Gem Patients
Serious events: 17 serious events
Other events: 34 other events
Deaths: 2 deaths
Carbo/Gem
Serious events: 1 serious events
Other events: 15 other events
Deaths: 1 deaths
All@Patients
Serious events: 18 serious events
Other events: 49 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
MCS110 + Carbo/Gem
n=19 participants at risk
MCS110 + Carbo/Gem
|
MCS110 With C1D8@Dose + Carbo/Gem
n=15 participants at risk
MCS110 with C1D8@dose + Carbo/Gem
|
All MCS110 + @Carbo/Gem Patients
n=34 participants at risk
All MCS110 + @Carbo/Gem Patients
|
Carbo/Gem
n=15 participants at risk
Carbo/Gem
|
All@Patients
n=49 participants at risk
All@Patients
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Blood and lymphatic system disorders
Atypical haemolytic uraemic syndrome
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Fatigue
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Generalised oedema
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Device related infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Erysipelas
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Genital infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Infection
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Mastitis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Renal and urinary disorders
Renal failure
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
Other adverse events
| Measure |
MCS110 + Carbo/Gem
n=19 participants at risk
MCS110 + Carbo/Gem
|
MCS110 With C1D8@Dose + Carbo/Gem
n=15 participants at risk
MCS110 with C1D8@dose + Carbo/Gem
|
All MCS110 + @Carbo/Gem Patients
n=34 participants at risk
All MCS110 + @Carbo/Gem Patients
|
Carbo/Gem
n=15 participants at risk
Carbo/Gem
|
All@Patients
n=49 participants at risk
All@Patients
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
68.4%
13/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
66.7%
10/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
67.6%
23/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
66.7%
10/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
67.3%
33/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
17.6%
6/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
18.4%
9/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
52.6%
10/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
53.3%
8/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
52.9%
18/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
53.3%
8/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
53.1%
26/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
42.1%
8/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
53.3%
8/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
47.1%
16/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
53.3%
8/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
49.0%
24/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Cardiac disorders
Bradycardia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Cardiac disorders
Tachycardia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Endocrine disorders
Hypothyroidism
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Diplopia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Dry eye
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Eye oedema
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Eye pain
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Eyelid oedema
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Foreign body sensation in eyes
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Lacrimation increased
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Orbital oedema
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Periorbital oedema
|
42.1%
8/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
40.0%
6/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
41.2%
14/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
28.6%
14/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Periorbital swelling
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
21.1%
4/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
16.3%
8/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Chapped lips
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Constipation
|
26.3%
5/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
23.5%
8/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.4%
10/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
5/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.4%
10/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
12.2%
6/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Lip oedema
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Nausea
|
52.6%
10/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
80.0%
12/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
64.7%
22/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
53.3%
8/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
61.2%
30/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Stomatitis
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
16.3%
8/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Gastrointestinal disorders
Vomiting
|
26.3%
5/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
23.5%
8/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.4%
10/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Asthenia
|
26.3%
5/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
23.5%
8/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
24.5%
12/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Chest discomfort
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Chills
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
11.8%
4/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Device related thrombosis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Face oedema
|
21.1%
4/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
14.3%
7/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Facial pain
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Fatigue
|
31.6%
6/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
60.0%
9/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
44.1%
15/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
38.8%
19/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Gait disturbance
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
General physical health deterioration
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Infusion site extravasation
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Infusion site pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Injection site swelling
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Oedema peripheral
|
15.8%
3/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
16.3%
8/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Peripheral swelling
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Pyrexia
|
21.1%
4/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
18.4%
9/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Swelling
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Swelling face
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
General disorders
Xerosis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Bronchitis viral
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Candida infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Catheter site infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Cystitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Ear infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Folliculitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Fungal oesophagitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Gingivitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Lower respiratory tract infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Lymphangitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Mastitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Nail infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Oral candidiasis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Oral infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Oropharyngeal candidiasis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Spinal cord infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
10.2%
5/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Chemical cystitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Oral contusion
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Alanine aminotransferase increased
|
63.2%
12/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
80.0%
12/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
70.6%
24/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
53.1%
26/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Amylase increased
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
84.2%
16/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
80.0%
12/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
82.4%
28/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
65.3%
32/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Blood alkaline phosphatase increased
|
21.1%
4/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
14.7%
5/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
10.2%
5/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Blood creatine phosphokinase MB increased
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Blood creatine phosphokinase increased
|
47.4%
9/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
46.7%
7/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
47.1%
16/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
32.7%
16/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Blood iron decreased
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
C-reactive protein increased
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
26.3%
5/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
17.6%
6/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
12.2%
6/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Haemoglobin decreased
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Hepatic enzyme increased
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Lipase
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Lipase increased
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Lymphocyte count decreased
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Neutrophil count decreased
|
31.6%
6/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
32.4%
11/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
32.7%
16/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Platelet count decreased
|
15.8%
3/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
17.6%
6/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
40.0%
6/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
24.5%
12/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
Weight increased
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Investigations
White blood cell count decreased
|
15.8%
3/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
16.3%
8/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.8%
3/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
18.4%
9/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Fluid retention
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.8%
3/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
11.8%
4/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
10.2%
5/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Ageusia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Balance disorder
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
22.4%
11/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Neuralgia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Nervous system disorders
Vocal cord paralysis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Product Issues
Device dislocation
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Psychiatric disorders
Anxiety
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
11.8%
4/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
10.2%
5/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Psychiatric disorders
Depressed mood
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Renal and urinary disorders
Nocturia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Reproductive system and breast disorders
Breast oedema
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.6%
7/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
14.3%
7/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.6%
6/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
32.4%
11/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.5%
13/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
11.8%
4/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
12.2%
6/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
11.8%
4/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.8%
3/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.1%
3/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
20.0%
3/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
14.7%
5/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
10.2%
5/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.3%
5/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
33.3%
5/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
29.4%
10/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
26.7%
4/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
28.6%
14/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
5.9%
2/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Flushing
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Haematoma
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Hot flush
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Hypertension
|
15.8%
3/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
11.8%
4/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
8.2%
4/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Jugular vein thrombosis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Phlebitis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Poor venous access
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
4.1%
2/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
|
Vascular disorders
Thrombosis
|
5.3%
1/19 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.9%
1/34 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
2.0%
1/49 • Adverse events were collected from first dose of study treatment until end of study treatment plus up to 150 days post treatment, up to maximum duration of 5 years
|
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