Trial Outcomes & Findings for Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA (NCT NCT04097379)
NCT ID: NCT04097379
Last Updated: 2026-01-30
Results Overview
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee. Change from baseline in cartilage volume was analyzed using the mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Baseline, Week 28
Results posted on
2026-01-30
Participant Flow
Participants took part in 1 investigative site in Netherlands.
This study had a 7-week screening period.
Participant milestones
| Measure |
LRX712 75 mg
LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15 mg
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
16
|
12
|
14
|
|
Overall Study
COMPLETED
|
3
|
16
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
LRX712 75 mg
LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15 mg
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Preliminary Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Knee OA
Baseline characteristics by cohort
| Measure |
LRX712 15 mg
n=12 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 75 mg
n=3 Participants
LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=16 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 7.74 • n=41 Participants
|
61.6 years
STANDARD_DEVIATION 7.31 • n=1581 Participants
|
59.7 years
STANDARD_DEVIATION 5.03 • n=4626 Participants
|
58.4 years
STANDARD_DEVIATION 8.66 • n=72 Participants
|
61.6 years
STANDARD_DEVIATION 8.20
|
|
Sex: Female, Male
Female
|
5 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
7 Participants
n=72 Participants
|
20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
9 Participants
n=72 Participants
|
25 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=41 Participants
|
13 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
16 Participants
n=72 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 28Population: Participants in the safety analysis set from the arms "LRX712 15 mg", "LRX712 25 mg" and "Placebo" who had an available value for the outcome measure as aligned with protocol. The Safety Set comprises all enrolled participants who received any investigational treatment.
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee. Change from baseline in cartilage volume was analyzed using the mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR).
Outcome measures
| Measure |
LRX712 15 mg
n=11 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=13 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=16 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Change From Baseline in Cartilage Volume in the Index Region Measured by 7 Tesla MRI
|
63.3 µL
Standard Error 54.93
|
49.8 µL
Standard Error 50.57
|
11.6 µL
Standard Error 45.54
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57Population: Pharmacokinetic (PK) analysis set: Includes all participants with at least one available valid PK concentration measurement, who received any dose of LRX712 and with no protocol deviations that impact on PK data.
Tmax is the time to reach maximum (peak) LRX712 concentration after single-dose administration (time). LRX712 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 25 pg/mL.
Outcome measures
| Measure |
LRX712 15 mg
n=12 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=3 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of LRX712
Day 1
|
17.5 hours
Interval 12.0 to 24.0
|
23.3 hours
Interval 0.5 to 24.1
|
24.0 hours
Interval 12.0 to 24.1
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of LRX712
Day 29
|
23.8 hours
Interval 22.6 to 24.0
|
24.0 hours
Interval 22.2 to 24.2
|
23.9 hours
Interval 23.8 to 24.0
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of LRX712
Day 57
|
24.0 hours
Interval 21.9 to 24.0
|
24.0 hours
Interval 22.0 to 24.1
|
24.0 hours
Interval 23.5 to 24.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57Population: Pharmacokinetic (PK) analysis set: Includes all participants with at least one available valid PK concentration measurement, who received any dose of LRX712 and with no protocol deviations that impact on PK data.
Cmax is defined as the maximum (peak) observed concentration following a dose. LRX712 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 25 pg/mL.
Outcome measures
| Measure |
LRX712 15 mg
n=12 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=3 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of LRX712
Day 1
|
3.52 ng/mL
Standard Deviation 2.07
|
6.54 ng/mL
Standard Deviation 5.33
|
6.94 ng/mL
Standard Deviation 4.96
|
|
Maximum Observed Plasma Concentration (Cmax) of LRX712
Day 29
|
3.33 ng/mL
Standard Deviation 2.57
|
3.50 ng/mL
Standard Deviation 1.43
|
27.0 ng/mL
Standard Deviation 31.6
|
|
Maximum Observed Plasma Concentration (Cmax) of LRX712
Day 57
|
2.39 ng/mL
Standard Deviation 0.951
|
4.05 ng/mL
Standard Deviation 2.25
|
29.5 ng/mL
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Pre-dose on Day 29; Pre-dose, 1344 hours after dose on Day 57 (LRX712 15 mg arm) and 3360 hours after dose on Day 57 (LRX712 25 mg and 75 mg arms)Population: Pharmacokinetic (PK) analysis set: Includes all participants with at least one available valid PK concentration measurement, who received any dose of LRX712 and with no protocol deviations that impact on PK data.
Cmin is defined as the minimum (peak) observed concentration following a dose. LRX712 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 25 pg/mL.
Outcome measures
| Measure |
LRX712 15 mg
n=11 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=3 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of LRX712
Dose 1 (pre-dose Day 29)
|
0.0735 ng/mL
Standard Deviation 0.10
|
0.0823 ng/mL
Standard Deviation 0.115
|
0.231 ng/mL
Standard Deviation 0.401
|
|
Minimum Observed Plasma Concentration (Cmin) of LRX712
Dose 2 (pre-dose Day 57)
|
0.111 ng/mL
Standard Deviation 0.109
|
0.202 ng/mL
Standard Deviation 0.204
|
0.365 ng/mL
Standard Deviation 0.585
|
|
Minimum Observed Plasma Concentration (Cmin) of LRX712
Dose 3 (post-dose Day 57)
|
0.0439 ng/mL
Standard Deviation 0.0740
|
0.00379 ng/mL
Standard Deviation 0.0131
|
0.0120 ng/mL
Standard Deviation 0.0208
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, 29 and 57Population: Participants in the PK analysis set with a synovial sample collected and a valid value for the outcome measure.
The observed synovial concentration following a dose. LRX712 concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). LRX712 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 20 ng/mL. Samples were collected from a limited number of participants.
Outcome measures
| Measure |
LRX712 15 mg
n=2 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=3 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Synovial Fluid Concentrations of LRX712
Day 1
|
0 ng/mL
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Synovial Fluid Concentrations of LRX712
Day 29
|
0 ng/mL
|
0 ng/mL
|
—
|
|
Synovial Fluid Concentrations of LRX712
Day 57
|
—
|
0 ng/mL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57Population: Pharmacokinetic (PK) analysis set: Includes all participants with at least one available valid PK concentration measurement, who received any dose of LRX712 and with no protocol deviations that impact on PK data.
Tmax is the time to reach maximum (peak) MAE344 concentration after single-dose administration (time). MAE344 is a metabolite of LRX712 and plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 100 pg/mL.
Outcome measures
| Measure |
LRX712 15 mg
n=12 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=3 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of MAE344
Day 1
|
23.5 hours
Interval 12.0 to 24.1
|
24.0 hours
Interval 12.0 to 169.0
|
24.1 hours
Interval 24.0 to 24.1
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of MAE344
Day 29
|
23.8 hours
Interval 22.6 to 24.0
|
24.0 hours
Interval 22.2 to 193.0
|
23.9 hours
Interval 23.8 to 24.0
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of MAE344
Day 57
|
24.0 hours
Interval 21.9 to 169.0
|
24.0 hours
Interval 22.0 to 24.1
|
24.0 hours
Interval 23.5 to 24.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 12, 24 and 168 hours after dose on Day 1; Pre-dose, 24 and 168 hours after dose on Day 29; Pre-dose, 24, 168, 1344 and 3360 hours after dose on Day 57Population: Pharmacokinetic (PK) analysis set: Includes all participants with at least one available valid PK concentration measurement, who received any dose of LRX712 and with no protocol deviations that impact on PK data.
Cmax is defined as the maximum (peak) observed concentration following a dose. MAE344 is a metabolite of LRX712 and plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 100 pg/mL.
Outcome measures
| Measure |
LRX712 15 mg
n=12 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=3 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of MAE344
Day 1
|
38.3 ng/mL
Standard Deviation 23.0
|
52.1 ng/mL
Standard Deviation 47.3
|
75.2 ng/mL
Standard Deviation 63.1
|
|
Maximum Observed Plasma Concentration (Cmax) of MAE344
Day 29
|
42.6 ng/mL
Standard Deviation 37.4
|
40.5 ng/mL
Standard Deviation 24.6
|
281 ng/mL
Standard Deviation 329
|
|
Maximum Observed Plasma Concentration (Cmax) of MAE344
Day 57
|
26.0 ng/mL
Standard Deviation 11.8
|
45.1 ng/mL
Standard Deviation 33.7
|
321 ng/mL
Standard Deviation 170
|
SECONDARY outcome
Timeframe: Pre-dose on Day 29; Pre-dose, 1344 hours after dose on Day 57 (LRX712 15 mg arm) and 3360 hours after dose on Day 57 (LRX712 25 mg and 75 mg arms)Population: Pharmacokinetic (PK) analysis set: Includes all participants with at least one available valid PK concentration measurement, who received any dose of LRX712 and with no protocol deviations that impact on PK data.
Cmin is defined as the minimum (peak) observed concentration following a dose. MAE344 is a metabolite of LRX712 and plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 100 pg/mL.
Outcome measures
| Measure |
LRX712 15 mg
n=11 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=3 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of MAE344
Dose 1 (pre-dose Day 29)
|
1.34 ng/mL
Standard Deviation 1.76
|
1.49 ng/mL
Standard Deviation 1.82
|
4.11 ng/mL
Standard Deviation 7.01
|
|
Minimum Observed Plasma Concentration (Cmin) of MAE344
Dose 2 (pre-dose Day 57)
|
2.12 ng/mL
Standard Deviation 2.15
|
3.04 ng/mL
Standard Deviation 3.06
|
5.70 ng/mL
Standard Deviation 9.10
|
|
Minimum Observed Plasma Concentration (Cmin) of MAE344
Dose 3 (post-dose Day 57)
|
0.916 ng/mL
Standard Deviation 1.22
|
0.0557 ng/mL
Standard Deviation 0.140
|
0.257 ng/mL
Standard Deviation 0.445
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, 29 and 57Population: Participants in the PK analysis set with a synovial sample collected and a valid value for the outcome measure.
The observed synovial concentration following a dose. MAE344 is a metabolite of LRX712 and concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). MAE344 was determined by a validated LC-MS/MS method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero" . LLOQ was 80 ng/mL. Samples were collected from a limited number of participants.
Outcome measures
| Measure |
LRX712 15 mg
n=2 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=3 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Synovial Fluid Concentrations of MAE344
Day 1
|
0 ng/mL
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Synovial Fluid Concentrations of MAE344
Day 29
|
0 ng/mL
|
0 ng/mL
|
—
|
|
Synovial Fluid Concentrations of MAE344
Day 57
|
—
|
0 ng/mL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, 28 and 52Population: Participants in the safety analysis set from the arms "LRX712 15 mg", "LRX712 25 mg" and "Placebo" who had an available value for the outcome measure as aligned with protocol. The Safety Set comprises all enrolled participants who received any investigational treatment.
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in articular cartilage quality (assessed by changes in glycosaminoglycans content measured by sodium content) in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee quality. Change from baseline in articular cartilage content was analyzed using a mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR). The data from the three participants who completed dosing with 75 mg LRX712 were considered exploratory.
Outcome measures
| Measure |
LRX712 15 mg
n=9 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=11 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=16 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Change From Baseline in Articular Cartilage [23Na] Content Measured by 7 Tesla MRI
Week 16
|
-7.4 mmol/L
Standard Error 12.00
|
12.7 mmol/L
Standard Error 11.99
|
8.5 mmol/L
Standard Error 9.20
|
|
Change From Baseline in Articular Cartilage [23Na] Content Measured by 7 Tesla MRI
Week 28
|
-15.5 mmol/L
Standard Error 11.21
|
8.9 mmol/L
Standard Error 11.13
|
4.0 mmol/L
Standard Error 9.24
|
|
Change From Baseline in Articular Cartilage [23Na] Content Measured by 7 Tesla MRI
Week 52
|
3.1 mmol/L
Standard Error 12.12
|
26.6 mmol/L
Standard Error 11.19
|
5.5 mmol/L
Standard Error 9.20
|
SECONDARY outcome
Timeframe: Baseline, Week 16 and 52Population: Participants in the safety analysis set from the arms "LRX712 15 mg", "LRX712 25 mg" and "Placebo" who had an available value for the outcome measure as aligned with protocol. The Safety Set comprises all enrolled participants who received any investigational treatment.
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee quality. Change from baseline in cartilage volume was analyzed using a mixed effects model for repeated measures (MMRM). The model included baseline, treatment, timepoint and treatment-timepoints as fixed effects, and participant as random effect. Missing data was assumed to be Missing at Random (MAR). The data from the three participants who completed dosing with 75 mg LRX712 were considered exploratory.
Outcome measures
| Measure |
LRX712 15 mg
n=11 Participants
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=13 Participants
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=16 Participants
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
|---|---|---|---|
|
Change From Baseline in Cartilage Volume in the Index Region Measured by 7 Tesla MRI
Week 16
|
-48.0 µL
Standard Error 52.64
|
-17.4 µL
Standard Error 50.09
|
24.4 µL
Standard Error 43.05
|
|
Change From Baseline in Cartilage Volume in the Index Region Measured by 7 Tesla MRI
Week 52
|
19.5 µL
Standard Error 73.11
|
49.3 µL
Standard Error 67.29
|
123.1 µL
Standard Error 60.62
|
Adverse Events
LRX712 15 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LRX712 25 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
LRX712 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LRX712 15mg and 25mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
LRX712 15 mg_Post-treatment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
LRX712 25 mg_Post-treatment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
LRX712 75 mg_Post-treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LRX712 15mg and 25mg_Post-treatment
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo_Post-treatment
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Total
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LRX712 15 mg
n=12 participants at risk
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 participants at risk
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 75 mg
n=3 participants at risk
LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15mg and 25mg
n=26 participants at risk
LRX712 was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=16 participants at risk
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15 mg_Post-treatment
n=12 participants at risk
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg_Post-treatment
n=14 participants at risk
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 75 mg_Post-treatment
n=3 participants at risk
LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15mg and 25mg_Post-treatment
n=26 participants at risk
LRX712 was administered i.a. every four weeks, for a total of three administrations.
|
Placebo_Post-treatment
n=16 participants at risk
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
Total
n=45 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
Other adverse events
| Measure |
LRX712 15 mg
n=12 participants at risk
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg
n=14 participants at risk
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 75 mg
n=3 participants at risk
LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15mg and 25mg
n=26 participants at risk
LRX712 was administered i.a. every four weeks, for a total of three administrations.
|
Placebo
n=16 participants at risk
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15 mg_Post-treatment
n=12 participants at risk
LRX712 15 mg was administered intra-articularly (i.a.) every four weeks, for a total of three administrations.
|
LRX712 25 mg_Post-treatment
n=14 participants at risk
LRX712 25 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 75 mg_Post-treatment
n=3 participants at risk
LRX712 75 mg was administered i.a. every four weeks, for a total of three administrations.
|
LRX712 15mg and 25mg_Post-treatment
n=26 participants at risk
LRX712 was administered i.a. every four weeks, for a total of three administrations.
|
Placebo_Post-treatment
n=16 participants at risk
Placebo was administered i.a. every four weeks, for a total of three administrations.
|
Total
n=45 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.7%
2/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.7%
3/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
18.8%
3/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
8.9%
4/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.7%
2/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.7%
3/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Feeling cold
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
33.3%
1/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Injection site haematoma
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Injection site reaction
|
16.7%
2/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
100.0%
3/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
11.5%
3/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
25.0%
4/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
22.2%
10/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Malaise
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Gastrointestinal infection
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.7%
2/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
18.8%
3/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
11.1%
5/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
57.1%
8/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
33.3%
1/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
50.0%
13/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
75.0%
12/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
12.5%
2/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
60.0%
27/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
41.7%
5/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
14.3%
2/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
26.9%
7/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
25.0%
4/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
25.0%
3/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
14.3%
2/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
19.2%
5/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
25.0%
4/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
35.6%
16/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.7%
3/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
25.0%
3/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
50.0%
7/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
38.5%
10/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
22.2%
10/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
14.3%
2/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
11.5%
3/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
18.8%
3/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
13.3%
6/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
18.8%
3/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.7%
3/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
33.3%
1/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
14.3%
2/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.7%
2/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.7%
3/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
4.4%
2/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
6.2%
1/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
7.1%
1/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
3.8%
1/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/12 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/14 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/3 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/26 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
0.00%
0/16 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
2.2%
1/45 • Adverse events were reported as "on-treatment" from first dose until last dose of study treatment plus 30 days and as "follow up" from last dose of study treatment plus 29 days up to a maximum duration of approximately 52 weeks.
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER