Trial Outcomes & Findings for MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS) (NCT NCT01643850)
NCT ID: NCT01643850
Last Updated: 2021-01-05
Results Overview
To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Week 4
Results posted on
2021-01-05
Participant Flow
Thirty-seven subjects diagnosed with PVNS or GCTTS were evaluated as part of this study. In all, 36 subjects were treated in three parts (Parts A, B and C) of the study, 30 of whom completed the study. At this final analysis, 6 treated subjects had discontinued from the study.
Participant milestones
| Measure |
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
|
Placebo (PART A)
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
|
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
|
Placebo/10mg/kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 5 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
8
|
3
|
3
|
3
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
5
|
2
|
7
|
3
|
0
|
3
|
3
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
3
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
|
Placebo (PART A)
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
|
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
|
Placebo/10mg/kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 5 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Administrative Problems
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Baseline characteristics by cohort
| Measure |
MCS110 10 mg/kg (PART A)
n=5 Participants
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
|
Placebo (PART A)
n=2 Participants
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
|
MCS110 10 mg/kg (PART B)
n=8 Participants
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
|
Placebo/10mg/kg (PART B)
n=3 Participants
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3 mg/kg (Part C)
n=3 Participants
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 5 mg/kg (Part C)
n=3 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (Part C)
n=4 Participants
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
n=4 Participants
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.4 Years
STANDARD_DEVIATION 8.96 • n=99 Participants
|
30.0 Years
STANDARD_DEVIATION 4.24 • n=107 Participants
|
46.3 Years
STANDARD_DEVIATION 10.14 • n=206 Participants
|
26.7 Years
STANDARD_DEVIATION 11.59 • n=7 Participants
|
45.7 Years
STANDARD_DEVIATION 17.93 • n=31 Participants
|
38.0 Years
STANDARD_DEVIATION 21.66 • n=30 Participants
|
43.8 Years
STANDARD_DEVIATION 13.38 • n=3 Participants
|
46.3 Years
STANDARD_DEVIATION 2.87 • n=6 Participants
|
29.0 Years
STANDARD_DEVIATION 6.06 • n=114 Participants
|
41.3 Years
STANDARD_DEVIATION 12.91
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
22 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
14 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
31 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Pharmacodynamic Analysis Set
To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=17 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
|
-4222.8 mm3
Standard Deviation 6284.56
|
-668.5 mm3
Standard Deviation 18751.44
|
-9998.4 mm3
Standard Deviation 15628.40
|
-38002.1 mm3
Standard Deviation 57314.73
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: Pharmacodynamic Analysis Set
To assess the efficacy of a single i.v. dose of MCS110 in percent change of the PVNS tumor volume at week 4 as compared to baseline and compared to placebo evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients who received at least a single dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=17 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
|
-7.7 Percentage
Standard Deviation 5.10
|
-7.4 Percentage
Standard Deviation 13.21
|
-24.8 Percentage
Standard Deviation 23.42
|
-32.6 Percentage
Standard Deviation 16.61
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks post last dosePopulation: Pharmacodynamic Analysis Set
Assessment of maximum efficacy (multiple i.v.monthly doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 \& 10 mg/kg or 5 \& 10 mg/kg in changing PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Analysis included data starting from 1st dose of MCS110 in all treatment groups of Parts B and C. Part B patients who received placebo as 1st dose, measurement prior to receiving first dose of MCS110, was used as baseline and assessment time-points were adjusted accordingly. For Part C, participants starting treatment with low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and tumor volume reduction was ≤ 45%. Analysis includes data from patients who received at least 2 doses. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg \[3/10 mg/kg\] or after 3 doses of 5 mg/kg to 10 mg/kg \[5/10 mg/kg\]
Outcome measures
| Measure |
Placebo (PART ABC4)
n=7 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
|
-2450.3 mm3
Standard Deviation 2721.24
|
-29164.3 mm3
Standard Deviation 23286.18
|
-37015.1 mm3
Standard Deviation 29297.02
|
-42420.1 mm3
Standard Deviation 63812.69
|
-3571.9 mm3
Standard Deviation 3612.97
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks post last dosePopulation: Pharmacodynamic Analysis Set
To assess the maximum efficacy of multiple monthly i.v. doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 and 10 mg/kg or 5 and 10 mg/kg by percent change in the PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Subjects starting treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from all participants who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg \[3/10 mg/kg\] or after 3 doses of 5 mg/kg to 10 mg/kg \[5/10 mg/kg\].
Outcome measures
| Measure |
Placebo (PART ABC4)
n=7 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
|
-29.7 Percentage
Standard Deviation 33.73
|
-56.3 Percentage
Standard Deviation 20.31
|
-55.0 Percentage
Standard Deviation 19.02
|
-45.8 Percentage
Standard Deviation 40.11
|
-22.6 Percentage
Standard Deviation 16.21
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 2 yearsPopulation: Safety Analysis Set
Overall incidence of Adverse Events
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=2 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=11 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=7 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=7 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
n=12 Participants
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
AEs of mild severity
|
3 Participants
|
1 Participants
|
11 Participants
|
1 Participants
|
7 Participants
|
6 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
AEs of moderate severity
|
1 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
AEs of severe severity
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Study drug related AEs
|
3 Participants
|
1 Participants
|
10 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Serious AEs
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events
AEs leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)Population: Pharmacokinetic Analysis Set
Pharmacokinetic for a single dose of MCS110 for serum concentration -time curve (AUC).
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=8 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=6 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=7 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)
Day 1
|
75632187 h* ng/mL
Standard Deviation 16664282
|
44258092 h* ng/mL
Standard Deviation 6489002
|
—
|
12900096 h* ng/mL
Standard Deviation 2373049
|
14559871 h* ng/mL
Standard Deviation 7783073
|
44854588 h* ng/mL
Standard Deviation 9743190
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)
Day 29
|
—
|
—
|
838099 h* ng/mL
Standard Deviation 171148
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)
Day 85
|
—
|
256238447 h* ng/mL
Standard Deviation 140220044
|
—
|
—
|
179084.13 h* ng/mL
Standard Deviation 0
|
999719 h* ng/mL
Standard Deviation 278619
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)
Day 112
|
—
|
—
|
238619590 h* ng/mL
Standard Deviation 63815086
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)Population: Pharmacokinetic Analysis Set
Pharmacokinetic characterization of a single dose of MCS110 for maximum serum concentration (Cmax)
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=8 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=6 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=7 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of MCS110 Maximum Concentration (Cmax)
Day 1
|
234800 ng/mL
Standard Deviation 40598
|
206750 ng/mL
Standard Deviation 32745
|
—
|
66983 ng/mL
Standard Deviation 8493
|
85914 ng/mL
Standard Deviation 15539
|
214667 ng/mL
Standard Deviation 39119
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Maximum Concentration (Cmax)
Day 29
|
—
|
—
|
194667 ng/mL
Standard Deviation 36828
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Maximum Concentration (Cmax)
Day 85
|
—
|
309429 ng/mL
Standard Deviation 54464
|
—
|
—
|
97750 ng/mL
Standard Deviation 11667
|
255000 ng/mL
Standard Deviation 30199
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Maximum Concentration (Cmax)
Day 112
|
—
|
—
|
239000 ng/mL
Standard Deviation 55154
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)Population: Pharmacokinetic Analysis Set
Pharmacokinetic characterization of a single dose of MCS110 for time to maximum concentration (Tmax)
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=8 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=6 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=7 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)
Day 1
|
2.083 hour (h)
Interval 1.083 to 3.083
|
1.192 hour (h)
Interval 1.0 to 5.05
|
—
|
3.125 hour (h)
Interval 1.083 to 5.083
|
5 hour (h)
Interval 0.0 to 5.033
|
4 hour (h)
Interval 1.083 to 5.067
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)
Day 29
|
—
|
—
|
1.467 hour (h)
Interval 1.0 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)
Day 85
|
—
|
1.25 hour (h)
Interval 1.0 to 5.0
|
—
|
—
|
3.533 hour (h)
Interval 2.033 to 5.033
|
1.233 hour (h)
Interval 1.083 to 5.05
|
—
|
—
|
—
|
|
Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)
Day 112
|
—
|
—
|
3.1 hour (h)
Interval 1.017 to 5.183
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 85, Day 169Population: Pharmacokinetic Analysis Set
Pharmacokinetic characterization of a single dose of MCS110 for evaluation of macrophage-colony stimulating factor (M-CSF) plasma concentrations over time
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=2 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=8 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=6 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=7 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time
Baseline
|
4694.0 pg/mL
Standard Deviation 1375.40
|
4940.0 pg/mL
Standard Deviation 650.54
|
5767.1 pg/mL
Standard Deviation 1159.12
|
5056.7 pg/mL
Standard Deviation 1769.67
|
4778.3 pg/mL
Standard Deviation 2078.12
|
5420.0 pg/mL
Standard Deviation 3126.20
|
3360.0 pg/mL
Standard Deviation 747.46
|
—
|
—
|
|
Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time
Day 1
|
4762.5 pg/mL
Standard Deviation 2256.34
|
5060.0 pg/mL
Standard Deviation 0
|
6405.0 pg/mL
Standard Deviation 4103.80
|
4916.7 pg/mL
Standard Deviation 545.19
|
4688.3 pg/mL
Standard Deviation 1506.46
|
5281.4 pg/mL
Standard Deviation 2687.57
|
4423.3 pg/mL
Standard Deviation 1134.43
|
—
|
—
|
|
Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time
Day 85
|
1697500.0 pg/mL
Standard Deviation 646445.41
|
4235.0 pg/mL
Standard Deviation 544.47
|
4238571.4 pg/mL
Standard Deviation 1446575.60
|
4526666.7 pg/mL
Standard Deviation 1127578.53
|
4750000.0 pg/mL
Standard Deviation 0
|
4060000.0 pg/mL
Standard Deviation 0
|
4580000.0 pg/mL
Standard Deviation 575065.21
|
—
|
—
|
|
Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time
Day 169
|
173750.0 pg/mL
Standard Deviation 103345.30
|
469.0 pg/mL
Standard Deviation 1357.65
|
5668750.0 pg/mL
Standard Deviation 1928829.68
|
5360000.0 pg/mL
Standard Deviation 1173797.26
|
2290000.0 pg/mL
Standard Deviation 0
|
4090000.0 pg/mL
Standard Deviation 0
|
5480000.0 pg/mL
Standard Deviation 1225724.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 24, Week 104Population: Pharmacodynamic analysis
Pharmacodynamic characterization of a single dose of MCS110 by measuring C-terminal telopeptide of Type 1 Collagen peptide (CTX-I), a biomarker of bone resorption. Data measured in participants from three arms: participants from Part A, B and C who received a single dose of 10 mg/kg and had assessment at week 4 (Part ABC4); participants from Part A and B who received placebo ; and participants from Part B and C who received multiple monthly doses of MCS110 (10 mg/kg.) Serum CTX-I data were generated in Part A and Part B. In Part C, samples were collected for serum bone CTX-I analysis. The analysis was not performed, as enough information on compound mode of action was obtained using creatine kinase (CK) and monocytes (hematology) data. Only data from 10mg/kg (single and multiple doses) are available.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=17 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=5 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=17 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).
Baseline
|
0.3 ng/mL
Interval 0.2 to 0.5
|
0.5 ng/mL
Interval 0.4 to 1.0
|
0.4 ng/mL
Interval 0.2 to 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).
Week 4
|
0.1 ng/mL
Interval 0.0 to 0.1
|
0.6 ng/mL
Interval 0.2 to 0.8
|
0.1 ng/mL
Interval 0.0 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).
Week 24
|
—
|
—
|
0.1 ng/mL
Interval 0.0 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).
Week 104
|
—
|
—
|
0.3 ng/mL
Interval 0.2 to 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, throughout the study up to Day 505Population: Safety analysis set
To assess the immunogenicity of MCS110 in serum anti-MCS110 antibody concentrations
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=2 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=8 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=3 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
n=4 Participants
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Negative Anti-MCS110 Antibody
Day 393
|
—
|
—
|
—
|
—
|
1 Number of Participants
|
2 Number of Participants
|
4 Number of Participants
|
4 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Negative Anti-MCS110 Antibody
Day 505
|
—
|
—
|
6 Number of Participants
|
—
|
1 Number of Participants
|
4 Number of Participants
|
4 Number of Participants
|
3 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Negative Anti-MCS110 Antibody
Baseline
|
5 Number of Participants
|
1 Number of Participants
|
8 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
4 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Negative Anti-MCS110 Antibody
Day 29
|
4 Number of Participants
|
2 Number of Participants
|
8 Number of Participants
|
3 Number of Participants
|
2 Number of Participants
|
4 Number of Participants
|
4 Number of Participants
|
4 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Negative Anti-MCS110 Antibody
Day 85
|
3 Number of Participants
|
2 Number of Participants
|
7 Number of Participants
|
3 Number of Participants
|
1 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Negative Anti-MCS110 Antibody
Day 127
|
3 Number of Participants
|
1 Number of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Negative Anti-MCS110 Antibody
Day 169
|
4 Number of Participants
|
2 Number of Participants
|
7 Number of Participants
|
1 Number of Participants
|
1 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
3 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Negative Anti-MCS110 Antibody
Day 336
|
—
|
—
|
7 Number of Participants
|
—
|
—
|
2 Number of Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: Pharmacodynamic Analysis Set
To assess the clinical response of joint range of motion following a single i.v. dose of MCS110 or placebo as compared to baseline 4 weeks post-dose evaluated in participants, who had a knee tumor, which was the majority of participants (75%). The analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=17 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Knee Extension
|
-7.3 Degree
Standard Deviation 4.99
|
-12.3 Degree
Standard Deviation 13.65
|
1.7 Degree
Standard Deviation 2.89
|
-10.3 Degree
Standard Deviation 26.69
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Knee Flexion
|
-2.8 Degree
Standard Deviation 8.85
|
3.7 Degree
Standard Deviation 13.5
|
13.7 Degree
Standard Deviation 19.76
|
-15.4 Degree
Standard Deviation 43.13
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24/28, Week 104Population: Pharmacodynamic analysis set
To assess the clinical response of joint range of motion following multiple dose treatment with MCS110 3, 5, or 10 mg/kg evaluated in participants with knee tumor, which was the majority of participants (75%). The data presented are changes from baseline in degree. Participants, who started treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg \[3/10 mg/kg\] or after 3 doses of 5 mg/kg to 10 mg/kg \[5/10 mg/kg\].
Outcome measures
| Measure |
Placebo (PART ABC4)
n=7 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=7 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Week 24/28: Knee extension
|
-10.0 Degree
Standard Deviation 0.00
|
0.0 Degree
Standard Deviation 0.0
|
-10.5 Degree
Standard Deviation 21.36
|
-26 Degree
Standard Deviation 0.0
|
1 Degree
Standard Deviation 1.73
|
—
|
—
|
—
|
—
|
|
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Week 24/28:(Knee Flexion)
|
-2.0 Degree
Standard Deviation 0.00
|
8 Degree
Standard Deviation 0.00
|
9.9 Degree
Standard Deviation 8.77
|
8 Degree
Standard Deviation 0.0
|
53.0 Degree
Standard Deviation 61.54
|
—
|
—
|
—
|
—
|
|
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Week 104:(Knee Extension)
|
—
|
0 Degree
Standard Deviation 0
|
-3.5 Degree
Standard Deviation 6.07
|
-28.0 Degree
Standard Deviation 0.00
|
2.5 Degree
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
Week 104: (Knee Flexion)
|
—
|
-6 Degree
Standard Deviation 0
|
7.5 Degree
Standard Deviation 11.56
|
10 Degree
Standard Deviation 0.00
|
70.0 Degree
Standard Deviation 70.71
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24, Week 28, Week 40, Week 48, Week 104Population: Pharmacodynamic analysis set
Measurement of the participant's pain with a 100 mm visual analog scale (VAS) following treatment with MCS110 3, 5, or 10 mg/kg evaluated. Data presented are changes from baseline in degree. Participants were asked to place a line perpendicular to the VAS line at the point that represented her/his pain intensity. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the participants mark, providing a score from 0-100. Analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg \[3/10 mg/kg\] or after 3 doses of 5 mg/kg to 10 mg/kg \[5/10 mg/kg\].
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Baseline
|
32 millimeters (mm)
Standard Deviation 4.24
|
9.3 millimeters (mm)
Standard Deviation 12.74
|
28.6 millimeters (mm)
Standard Deviation 21.82
|
39.3 millimeters (mm)
Standard Deviation 28.43
|
51.0 millimeters (mm)
Standard Deviation 15.64
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Week 4
|
22.5 millimeters (mm)
Standard Deviation 20.51
|
4 millimeters (mm)
Standard Deviation 5.29
|
22.5 millimeters (mm)
Standard Deviation 23.87
|
32.0 millimeters (mm)
Standard Deviation 24.54
|
48.5 millimeters (mm)
Standard Deviation 30.71
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Week 12
|
20 millimeters (mm)
Standard Deviation 0
|
2.7 millimeters (mm)
Standard Deviation 3.06
|
13.9 millimeters (mm)
Standard Deviation 16.01
|
27.5 millimeters (mm)
Standard Deviation 26.51
|
33 millimeters (mm)
Standard Deviation 26.72
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Week 24
|
0 millimeters (mm)
Standard Deviation 0
|
0 millimeters (mm)
Standard Deviation 0
|
21.4 millimeters (mm)
Standard Deviation 22.07
|
8.5 millimeters (mm)
Standard Deviation 9.33
|
20.3 millimeters (mm)
Standard Deviation 28.51
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Week 28
|
40 millimeters (mm)
Standard Deviation 0
|
10.7 millimeters (mm)
Standard Deviation 17.62
|
0 millimeters (mm)
Standard Deviation 0
|
0 millimeters (mm)
Standard Deviation 0
|
0 millimeters (mm)
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Week 40
|
31 millimeters (mm)
Standard Deviation 0
|
3.7 millimeters (mm)
Standard Deviation 5.51
|
31.0 millimeters (mm)
Standard Deviation 31.38
|
22 millimeters (mm)
Standard Deviation 15.81
|
25.7 millimeters (mm)
Standard Deviation 31.56
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Week 48
|
0 millimeters (mm)
Standard Deviation 0
|
0 millimeters (mm)
Standard Deviation 0
|
21.0 millimeters (mm)
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Week 104
|
0 millimeters (mm)
Standard Deviation 0
|
16.0 millimeters (mm)
Standard Deviation 18.03
|
22.4 millimeters (mm)
Standard Deviation 24.23
|
17.8 millimeters (mm)
Standard Deviation 13.02
|
25.7 millimeters (mm)
Standard Deviation 24.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 104Population: Pharmacodynamic analysis set
Time to relapse describes the time frame from baseline when the tumor volume increases again after the treatment with MCS110. To be considered a relapse tumor volume had to increase greater than 50% of the difference between tumor volume at baseline and the lowest tumor volume measured by MRI. In this assessment the Part B and Part C patients were analyzed separately. N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=11 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Relapse
|
337.0 Days
Standard Deviation 108.89
|
454.0 Days
Standard Deviation 0
|
477.0 Days
Standard Deviation 0
|
296.0 Days
Standard Deviation 103.24
|
NA Days
Standard Deviation NA
N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
|
NA Days
Standard Deviation NA
N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 104Population: Pharmacodynamic analysis set
Time to surgery describes the time frame from baseline to the time point when participants had surgical removement of PVNS tumor. This could be either residual tumor after the tumor volume was reduced or surgery due to relapse. In this assessment the Part B and Part C patients were analyzed separately. Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=11 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Surgery
|
387.0 Days
Standard Deviation 116.25
|
0 Days
Standard Deviation 0
|
0 Days
Standard Deviation 0
|
231.0 Days
Standard Deviation 0
|
NA Days
Standard Deviation NA
Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery
|
NA Days
Standard Deviation NA
Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: Pharmacodynamic analysis set
The mHAQ assesses 20 activities in 8 categories related to daily life, which are rated on a 4-point Likert scale. The mHAQ is calculated as the average of the single scores with the following scoring: without difficulty =0; with some difficulty =1; with much difficulty =2; unable to do =3. Total score is between 0 - 3.0. Values \<0.3 are considered normal. Data presented include only participants, who received multiple doses of MCS110.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Average of Health-Related Quality of Life Questionnaire Score for mHAQ
Baseline
|
0.3 Scores on a scale
Standard Deviation 0.35
|
0.1 Scores on a scale
Standard Deviation 0.22
|
0.3 Scores on a scale
Standard Deviation 0.20
|
0.3 Scores on a scale
Standard Deviation 0.33
|
0.9 Scores on a scale
Standard Deviation 0.52
|
—
|
—
|
—
|
—
|
|
Average of Health-Related Quality of Life Questionnaire Score for mHAQ
Week 104
|
—
|
0.1 Scores on a scale
Standard Deviation 0.14
|
0.2 Scores on a scale
Standard Deviation 0.18
|
0.1 Scores on a scale
Standard Deviation 0.19
|
0.3 Scores on a scale
Standard Deviation 0.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Up to Week 104Population: Pharmacodynamic analysis set
Blood samples were collected for the evaluation of CD14+ monocytes (using FACS) and CD14+ CD16+ monocytes. Based on preliminary analysis, the quality of the samples did not allow meaningful conclusions to be drawn. Thus, in Part B, the monocyte sample collection was discontinued.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=5 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=8 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
n=4 Participants
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of CD14+ Monocytes and Number of CD14 + Monocytes and CD16+ Monocytes
|
NA Number of Monocytes
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done.
|
NA Number of Monocytes
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done.
|
NA Number of Monocytes
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done.
|
NA Number of Monocytes
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
|
NA Number of Monocytes
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
|
NA Number of Monocytes
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
|
NA Number of Monocytes
Due to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)Population: Pharmacodynamic analysis set
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life (QOL), pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline-ADL
|
65.4 Score on a scale
Standard Deviation 3.12
|
69.1 Score on a scale
Standard Deviation 0.00
|
77.3 Score on a scale
Standard Deviation 7.87
|
70.6 Score on a scale
Standard Deviation 0.00
|
71.3 Score on a scale
Standard Deviation 30.16
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 4-ADL
|
79.4 Score on a scale
Standard Deviation 20.8
|
91.2 Score on a scale
Standard Deviation 0.00
|
86.5 Score on a scale
Standard Deviation 10.37
|
89.7 Score on a scale
Standard Deviation 0.00
|
76.0 Score on a scale
Standard Deviation 18.97
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 12-ADL
|
72.1 Score on a scale
Standard Deviation 0.00
|
97.1 Score on a scale
Standard Deviation 0.00
|
87.4 Score on a scale
Standard Deviation 15.10
|
94.1 Score on a scale
Standard Deviation 0.00
|
76.5 Score on a scale
Standard Deviation 23.53
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 24-ADL
|
55.9 Score on a scale
Standard Deviation 0.00
|
0 Score on a scale
Standard Deviation 0
|
89.6 Score on a scale
Standard Deviation 10.75
|
79.4 Score on a scale
Standard Deviation 0
|
73.0 Score on a scale
Standard Deviation 28.83
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 28-ADL
|
52.9 Score on a scale
Standard Deviation 0
|
83.8 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 40- ADL
|
79.4 Score on a scale
Standard Deviation 0
|
95.6 Score on a scale
Standard Deviation 0
|
73.5 Score on a scale
Standard Deviation 29.12
|
89.7 Score on a scale
|
89.0 Score on a scale
Standard Deviation 15.6
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 48-ADL
|
—
|
—
|
85.3 Score on a scale
Standard Deviation 13.50
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 72-ADL
|
48.5 Score on a scale
Standard Deviation 0
|
88.2 Score on a scale
Standard Deviation 0
|
78.7 Score on a scale
Standard Deviation 20.82
|
91.2 Score on a scale
Standard Deviation 0
|
100 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 104- ADL
|
—
|
77.9 Score on a scale
|
93.5 Score on a scale
Standard Deviation 7.74
|
97.1 Score on a scale
Standard Deviation 0
|
87.5 Score on a scale
Standard Deviation 17.68
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)Population: Pharmacodynamic analysis set
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline-Knee
|
15.6 Score on a scale
Standard Deviation 13.26
|
37.5 Score on a scale
Standard Deviation 0
|
29.5 Score on a scale
Standard Deviation 23.23
|
50.0 Score on a scale
Standard Deviation 0
|
40.6 Score on a scale
Standard Deviation 4.42
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 4-Knee
|
31.3 Score on a scale
Standard Deviation 17.68
|
56.3 Score on a scale
Standard Deviation 0
|
43.8 Score on a scale
Standard Deviation 22.88
|
43.8 Score on a scale
Standard Deviation 0
|
45.8 Score on a scale
Standard Deviation 13.01
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 12-Knee
|
37.5 Score on a scale
Standard Deviation 0
|
56.3 Score on a scale
Standard Deviation 0
|
54.4 Score on a scale
Standard Deviation 28.72
|
62.5 Score on a scale
Standard Deviation 0
|
43.8 Score on a scale
Standard Deviation 16.54
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 24-Knee
|
43.8 Score on a scale
Standard Deviation 0
|
—
|
50.7 Score on a scale
Standard Deviation 34.30
|
43.8 Score on a scale
Standard Deviation 0
|
41.7 Score on a scale
Standard Deviation 21.95
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 28-Knee
|
12.5 Score on a scale
Standard Deviation 0
|
56.3 Score on a scale
Standard Deviation 0
|
46.9 Score on a scale
Standard Deviation 0
|
68.8 Score on a scale
Standard Deviation 0
|
56.3 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 40- Knee
|
37.5 Score on a scale
Standard Deviation 0
|
62.5 Score on a scale
Standard Deviation 0
|
37.5 Score on a scale
Standard Deviation 0
|
50.0 Score on a scale
Standard Deviation 0
|
68.8 Score on a scale
Standard Deviation 8.84
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 48-Knee
|
—
|
—
|
48.4 Score on a scale
Standard Deviation 25.61
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 72-Knee
|
25.0 Score on a scale
Standard Deviation 0
|
56.3 Score on a scale
Standard Deviation 0
|
45.0 Score on a scale
Standard Deviation 26.81
|
68.8 Score on a scale
Standard Deviation 0
|
68.8 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 104- Knee
|
—
|
50.0 Score on a scale
Standard Deviation 0
|
59.8 Score on a scale
Standard Deviation 21.61
|
68.8 Score on a scale
Standard Deviation 0
|
62.5 Score on a scale
Standard Deviation 17.68
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)Population: Pharmacodynamic analysis set
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline
|
54.2 Score on a scale
Standard Deviation 5.89
|
52.8 Score on a scale
Standard Deviation 0
|
62.6 Score on a scale
Standard Deviation 17.50
|
66.7 Score on a scale
Standard Deviation 0
|
61.1 Score on a scale
Standard Deviation 23.57
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 4
|
66.7 Score on a scale
Standard Deviation 19.64
|
75.0 Score on a scale
Standard Deviation 0
|
73.5 Score on a scale
Standard Deviation 18.19
|
75.0 Score on a scale
Standard Deviation 0
|
63.0 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 12
|
55.6 Score on a scale
Standard Deviation 0
|
80.6 Score on a scale
Standard Deviation 0
|
75.6 Score on a scale
Standard Deviation 20.32
|
75.0 Score on a scale
Standard Deviation 0
|
71.3 Score on a scale
Standard Deviation 15.80
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 24
|
52.8 Score on a scale
Standard Deviation 0
|
—
|
77.5 Score on a scale
Standard Deviation 21.22
|
61.1 Score on a scale
Standard Deviation 0
|
69.4 Score on a scale
Standard Deviation 25.46
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 28
|
55.6 Score on a scale
Standard Deviation 0
|
69.4 Score on a scale
Standard Deviation 0
|
70.8 Score on a scale
Standard Deviation 41.25
|
83.3 Score on a scale
Standard Deviation 0
|
88.9 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 40
|
58.3 Score on a scale
Standard Deviation 0
|
77.8 Score on a scale
Standard Deviation 0
|
56.9 Score on a scale
Standard Deviation 0
|
80.6 Score on a scale
Standard Deviation 0
|
79.2 Score on a scale
Standard Deviation 21.61
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 48
|
—
|
—
|
71.5 Score on a scale
Standard Deviation 21.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 72
|
47.2 Score on a scale
Standard Deviation 0
|
66.7 Score on a scale
Standard Deviation 0
|
62.2 Score on a scale
Standard Deviation 25.43
|
88.9 Score on a scale
Standard Deviation 0
|
91.7 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 104
|
—
|
58.3 Score on a scale
Standard Deviation 0
|
77.7 Score on a scale
Standard Deviation 13.12
|
91.7 Score on a scale
Standard Deviation 0
|
72.2 Score on a scale
Standard Deviation 27.50
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)Population: Pharmacodynamic analysis set
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline
|
35.0 Score on a scale
Standard Deviation 7.07
|
25.0 Score on a scale
Standard Deviation 0
|
29.5 Score on a scale
Standard Deviation 23.15
|
70.0 Score on a scale
Standard Deviation 0
|
52.5 Score on a scale
Standard Deviation 31.82
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 4
|
50.0 Score on a scale
Standard Deviation 21.21
|
70.0 Score on a scale
Standard Deviation 0
|
40.9 Score on a scale
Standard Deviation 0
|
100.0 Score on a scale
Standard Deviation 0
|
48.3 Score on a scale
Standard Deviation 45.37
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 12
|
45.0 Score on a scale
Standard Deviation 0
|
85.0 Score on a scale
Standard Deviation 0
|
58.0 Score on a scale
Standard Deviation 0
|
85.0 Score on a scale
Standard Deviation 0
|
45.0 Score on a scale
Standard Deviation 37.75
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 24
|
30.0 Score on a scale
Standard Deviation 0
|
—
|
55.6 Score on a scale
Standard Deviation 30.66
|
50.0 Score on a scale
Standard Deviation 0
|
53.3 Score on a scale
Standard Deviation 37.53
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 28
|
35.0 Score on a scale
Standard Deviation 0
|
35.0 Score on a scale
Standard Deviation 0
|
50.0 Score on a scale
Standard Deviation 70.71
|
95.0 Score on a scale
Standard Deviation 0
|
95.0 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 40
|
35.0 Score on a scale
Standard Deviation 0
|
50.0 Score on a scale
Standard Deviation 0
|
37.5 Score on a scale
Standard Deviation 53.03
|
90.0 Score on a scale
Standard Deviation 0
|
80.0 Score on a scale
Standard Deviation 21.21
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 48
|
—
|
—
|
48.1 Score on a scale
Standard Deviation 39.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 72
|
30.0 Score on a scale
Standard Deviation 0
|
40.0 Score on a scale
Standard Deviation 0
|
40.6 Score on a scale
Standard Deviation 36.27
|
70.0 Score on a scale
Standard Deviation 0
|
95.0 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 104
|
—
|
30.0 Score on a scale
Standard Deviation 0
|
58.2 Score on a scale
Standard Deviation 21.54
|
95.0 Score on a scale
Standard Deviation 0
|
70.0 Score on a scale
Standard Deviation 35.36
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)Population: Pharmacodynamic analysis set
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Baseline
|
41.1 Score on a scale
Standard Deviation 12.63
|
50.0 Score on a scale
Standard Deviation 0
|
50.0 Score on a scale
Standard Deviation 16.44
|
50.0 Score on a scale
Standard Deviation 0
|
62.5 Score on a scale
Standard Deviation 27.78
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 4
|
58.9 Score on a scale
Standard Deviation 32.83
|
75.0 Score on a scale
Standard Deviation 0
|
59.4 Score on a scale
Standard Deviation 16.92
|
57.1 Score on a scale
Standard Deviation 0
|
57.1 Score on a scale
Standard Deviation 24.74
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 12
|
71.4 Score on a scale
Standard Deviation 0
|
78.6 Score on a scale
Standard Deviation 0
|
69.3 Score on a scale
Standard Deviation 21.31
|
64.3 Score on a scale
Standard Deviation 0
|
56.0 Score on a scale
Standard Deviation 26.33
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 24
|
50.0 Score on a scale
Standard Deviation 0
|
—
|
65.9 Score on a scale
Standard Deviation 25.45
|
67.9 Score on a scale
Standard Deviation 0
|
67.9 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 28
|
60.7 Score on a scale
Standard Deviation 0
|
60.7 Score on a scale
Standard Deviation 0
|
62.5 Score on a scale
Standard Deviation 53.03
|
75.0 Score on a scale
Standard Deviation 0
|
89.3 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 40
|
75.0 Score on a scale
Standard Deviation 0
|
64.3 Score on a scale
Standard Deviation 0
|
42.9 Score on a scale
Standard Deviation 60.61
|
78.6 Score on a scale
Standard Deviation 0
|
73.2 Score on a scale
Standard Deviation 37.88
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 48
|
—
|
—
|
62.1 Score on a scale
Standard Deviation 24.29
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 72
|
50.0 Score on a scale
Standard Deviation 0
|
57.1 Score on a scale
Standard Deviation 0
|
40.6 Score on a scale
Standard Deviation 28.43
|
78.6 Score on a scale
Standard Deviation 0
|
85.7 Score on a scale
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Week 104
|
—
|
53.6 Score on a scale
Standard Deviation 0
|
67.3 Score on a scale
Standard Deviation 20.63
|
85.7 Score on a scale
Standard Deviation 0
|
62.5 Score on a scale
Standard Deviation 32.83
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, Week 24, up to 104 weeksPopulation: Pharmacodynamic analysis set
The EQ-5D is a standardized measure of health status. The EQ visual analogue scale (EQ VAS)has a range from 0-100: worst possible to perfect health. Data show the absolute change from baseline of EQ5D VAS and at the different visits for participants, who received multiple doses of MCS110. (PART B and PART C).
Outcome measures
| Measure |
Placebo (PART ABC4)
n=3 Participants
Single dose placebo from PART A and B
|
MCS110 3 mg/kg (PART ABC4)
n=3 Participants
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
|
MCS110 5 mg/kg (PART ABC4)
n=15 Participants
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
|
MCS110 10 mg/kg (PART ABC4)
n=4 Participants
Single dose MCS110 10 mg/kg
|
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
n=4 Participants
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
|
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
|
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
|
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire
Week 4
|
11.0 Score on a scale
Standard Deviation 1.41
|
3.7 Score on a scale
Standard Deviation 5.03
|
0.6 Score on a scale
Standard Deviation 25.07
|
1.3 Score on a scale
Standard Deviation 2.50
|
5.5 Score on a scale
Standard Deviation 10.85
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire
Week 24
|
-1.0 Score on a scale
Standard Deviation 0.00
|
10.0 Score on a scale
Standard Deviation 0.00
|
9.5 Score on a scale
Standard Deviation 14.04
|
1.0 Score on a scale
Standard Deviation 8.54
|
9.8 Score on a scale
Standard Deviation 16.21
|
—
|
—
|
—
|
—
|
|
Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire
Up to Week 104
|
—
|
1.3 Score on a scale
Standard Deviation 5.51
|
6.9 Score on a scale
Standard Deviation 13.93
|
7.0 Score on a scale
Standard Deviation 8.91
|
18.0 Score on a scale
Standard Deviation 25.63
|
—
|
—
|
—
|
—
|
Adverse Events
MCS110 10 mg/kg (PART A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo (PART A)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
MCS110 10mg/kg (PART B)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo/10mg/kg (PART B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MCS110 3mg/kg (PART C)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
MCS110 5mg/kg (PART C)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
MCS110 10mg/kg (PART C)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCS110 10 mg/kg (PART A)
n=5 participants at risk
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
|
Placebo (PART A)
n=2 participants at risk
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
|
MCS110 10mg/kg (PART B)
n=11 participants at risk
MCS110 10 mg/kg (i.v. infusion)
|
Placebo/10mg/kg (PART B)
n=3 participants at risk
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3mg/kg (PART C)
n=7 participants at risk
MCS110 3 mg/kg (i.v. infusion)
|
MCS110 5mg/kg (PART C)
n=7 participants at risk
MCS110 5 mg/kg (i.v. infusion)
|
MCS110 10mg/kg (PART C)
n=12 participants at risk
MCS110 10 mg/kg (i.v. infusion)
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
50.0%
1/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Meningoencephalitis viral
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Viral infection
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Product Issues
Device dislocation
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
Other adverse events
| Measure |
MCS110 10 mg/kg (PART A)
n=5 participants at risk
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
|
Placebo (PART A)
n=2 participants at risk
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
|
MCS110 10mg/kg (PART B)
n=11 participants at risk
MCS110 10 mg/kg (i.v. infusion)
|
Placebo/10mg/kg (PART B)
n=3 participants at risk
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
|
MCS110 3mg/kg (PART C)
n=7 participants at risk
MCS110 3 mg/kg (i.v. infusion)
|
MCS110 5mg/kg (PART C)
n=7 participants at risk
MCS110 5 mg/kg (i.v. infusion)
|
MCS110 10mg/kg (PART C)
n=12 participants at risk
MCS110 10 mg/kg (i.v. infusion)
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Blepharitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Dark circles under eyes
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Eye swelling
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
27.3%
3/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Papilloedema
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
71.4%
5/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
42.9%
3/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
33.3%
4/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
50.0%
1/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
45.5%
5/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
42.9%
3/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
27.3%
3/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Administration site rash
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Chills
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Face oedema
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
71.4%
5/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Infusion site pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
33.3%
1/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
42.9%
3/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
25.0%
3/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
27.3%
3/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
General disorders
Swelling
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Influenza
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
25.0%
3/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Peritonsillitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
33.3%
1/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Infections and infestations
Viral infection
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Amylase increased
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Antinuclear antibody positive
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Blood creatine phosphokinase increased
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
50.0%
1/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Blood pressure increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Investigations
Lipase increased
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
33.3%
1/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
33.3%
1/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
25.0%
3/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign joint neoplasm
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
42.9%
3/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Hypoaesthesia
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Migraine
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
27.3%
3/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
36.4%
4/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
28.6%
2/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
16.7%
2/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin wrinkling
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
27.3%
3/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
8.3%
1/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
9.1%
1/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
18.2%
2/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
14.3%
1/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/2 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/11 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/3 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/7 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
0.00%
0/12 • Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER