Trial Outcomes & Findings for SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas (NCT NCT03894618)
NCT ID: NCT03894618
Last Updated: 2025-04-02
Results Overview
Number of participants with treatment emergent adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
From Day 1 to 90 days after Last Dose of SL-279252
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
SL-279252 (0.0001 mg/kg S1)
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
2
|
1
|
2
|
3
|
4
|
6
|
6
|
4
|
4
|
2
|
4
|
6
|
3
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
1
|
2
|
3
|
4
|
6
|
6
|
4
|
4
|
2
|
4
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas
Baseline characteristics by cohort
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=4 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=6 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=6 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
n=4 Participants
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
n=6 Participants
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
n=3 Participants
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.0 years
n=99 Participants
|
70.0 years
n=107 Participants
|
51.5 years
n=206 Participants
|
58.0 years
n=7 Participants
|
48.5 years
n=31 Participants
|
68.0 years
n=30 Participants
|
74.5 years
n=3 Participants
|
61.5 years
n=6 Participants
|
53.0 years
n=114 Participants
|
65.0 years
|
65.0 years
n=19 Participants
|
66.5 years
n=4 Participants
|
68.5 years
n=7 Participants
|
60.0 years
n=7 Participants
|
62.0 years
n=3 Participants
|
64.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
3 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 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
|
0 Participants
n=114 Participants
|
1 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
3 Participants
|
3 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
45 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 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
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 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
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
4 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 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
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
2 participants
n=31 Participants
|
3 participants
n=30 Participants
|
1 participants
n=3 Participants
|
2 participants
n=6 Participants
|
3 participants
n=114 Participants
|
1 participants
|
4 participants
n=19 Participants
|
1 participants
n=4 Participants
|
3 participants
n=7 Participants
|
0 participants
n=7 Participants
|
0 participants
n=3 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
1 participants
n=3 Participants
|
1 participants
n=6 Participants
|
1 participants
n=114 Participants
|
1 participants
|
0 participants
n=19 Participants
|
1 participants
n=4 Participants
|
0 participants
n=7 Participants
|
2 participants
n=7 Participants
|
2 participants
n=3 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 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
|
1 participants
n=3 Participants
|
2 participants
n=6 Participants
|
2 participants
n=114 Participants
|
1 participants
|
0 participants
n=19 Participants
|
0 participants
n=4 Participants
|
0 participants
n=7 Participants
|
3 participants
n=7 Participants
|
1 participants
n=3 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 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
|
1 participants
n=3 Participants
|
1 participants
n=6 Participants
|
0 participants
n=114 Participants
|
1 participants
|
0 participants
n=19 Participants
|
0 participants
n=4 Participants
|
1 participants
n=7 Participants
|
1 participants
n=7 Participants
|
0 participants
n=3 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to 90 days after Last Dose of SL-279252Number of participants with treatment emergent adverse events
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=4 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=6 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=6 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
n=4 Participants
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
n=6 Participants
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
n=3 Participants
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Profile of SL-279252
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 21 (Schedule 1) or Day 28 (Schedule 2)Population: DLT evaluable population
Number of participants with dose limiting toxicities (DLTs)
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=4 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=3 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=5 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=3 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
n=3 Participants
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
n=6 Participants
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
n=3 Participants
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of SL-279252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 32 monthsBased on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=49 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose for SL-279252
|
NA mg/kg
MTD/RP2D not achieved in this study
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 32 monthsPopulation: All treated population with solid tumors
Objective response rate per immune response evaluation criteria in solid tumors (iRECIST) for solid tumors
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=4 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=5 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=6 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
n=4 Participants
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
n=6 Participants
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
n=3 Participants
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate of SL-279252
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 32 monthsPopulation: For arms 0.0001 and 0.001 mg/kg of IV SL-279252, there were no subjects who were ADA negative at baseline. For arms 12.0 and 24.0 mg/kg of IV SL-279252, ADA samples were not collected.
Number of participants with positive anti-drug antibody (ADA) titer, of those who were ADA negative at baseline
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=1 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=2 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=3 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=5 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=4 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=3 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
n=2 Participants
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
n=5 Participants
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
n=3 Participants
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity to SL-279252
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were not available for analysis.
The Cmax is the maximum observed serum concentration of SL-279252 following single and multiple doses
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=8 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=12 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=9 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of SL-279252
Cycle 1 Day 15
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
3.22 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant
|
19.5 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
360 ng/mL
Geometric Coefficient of Variation 6.09
|
731 ng/mL
Geometric Coefficient of Variation 35.9
|
2920 ng/mL
Geometric Coefficient of Variation 52.9
|
10400 ng/mL
Geometric Coefficient of Variation 45.9
|
26100 ng/mL
Geometric Coefficient of Variation 67.0
|
75300 ng/mL
Geometric Coefficient of Variation 21.5
|
277000 ng/mL
Geometric Coefficient of Variation 10.5
|
349000 ng/mL
Geometric Coefficient of Variation 4.05
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of SL-279252
Cycle 1 Day 1
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
3.75 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant
|
30.8 ng/mL
Geometric Coefficient of Variation 4.60
|
93.4 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant
|
427 ng/mL
Geometric Coefficient of Variation 1.82
|
734 ng/mL
Geometric Coefficient of Variation 42.9
|
3580 ng/mL
Geometric Coefficient of Variation 29.6
|
10200 ng/mL
Geometric Coefficient of Variation 42.0
|
28100 ng/mL
Geometric Coefficient of Variation 43.0
|
83600 ng/mL
Geometric Coefficient of Variation 26.3
|
248000 ng/mL
Geometric Coefficient of Variation 34.7
|
320000 ng/mL
Geometric Coefficient of Variation 16.0
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of SL-279252
Cycle 2 Day 1 (Schedule 1 only)
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
50.6 ng/mL
Geometric Coefficient of Variation 49.2
|
—
|
408 ng/mL
Geometric Coefficient of Variation 13.0
|
1090 ng/mL
Geometric Coefficient of Variation 20.9
|
4260 ng/mL
Geometric Coefficient of Variation 24.2
|
9760 ng/mL
Geometric Coefficient of Variation 28.4
|
25400 ng/mL
Geometric Coefficient of Variation 103
|
94100 ng/mL
Geometric Coefficient of Variation 15.6
|
236000 ng/mL
Geometric Coefficient of Variation 25.8
|
355000 ng/mL
Geometric Coefficient of Variation 7.97
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of SL-279252
Cycle 2 Day 1 (Schedule 2 only)
|
—
|
—
|
—
|
—
|
—
|
—
|
4110 ng/mL
Geometric Coefficient of Variation 13.4
|
11700 ng/mL
Geometric Coefficient of Variation 36.9
|
38300 ng/mL
Geometric Coefficient of Variation 22.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 15 and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
The Cmin is the minimum observed serum concentration of SL-279252 following single and multiple doses
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=7 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=12 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=9 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=3 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=1 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Minimum Serum Concentration (Cmin) of SL-279252
Cycle 1 Day 15
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
1.03 ng/mL
Geometric Coefficient of Variation 71.9
|
3.77 ng/mL
Geometric Coefficient of Variation 56.5
|
10.4 ng/mL
Geometric Coefficient of Variation 124
|
29.0 ng/mL
Geometric Coefficient of Variation 43.0
|
90.7 ng/mL
Geometric Coefficient of Variation 100
|
12.7 ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant
|
—
|
—
|
—
|
|
Minimum Serum Concentration (Cmin) of SL-279252
Cycle 2 Day 1 (Schedule 2 only)
|
—
|
—
|
—
|
—
|
—
|
—
|
1.12 ng/mL
Geometric Coefficient of Variation 75.2
|
NA ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
11.9 ng/mL
Geometric Coefficient of Variation 164
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
The Tmax is the time at which the maximum concentration of SL-279252 is observed following single and multiple doses
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=8 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=12 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=9 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)
Cycle 2 Day 1 (Schedule 1 only)
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.38 hours
Interval 0.27 to 0.5
|
—
|
0.55 hours
Interval 0.52 to 0.58
|
0.58 hours
Interval 0.53 to 0.6
|
0.54 hours
Interval 0.42 to 0.58
|
1.05 hours
Interval 0.58 to 1.38
|
1.38 hours
Interval 1.02 to 3.02
|
1.00 hours
Interval 0.95 to 1.05
|
1.17 hours
Interval 1.08 to 1.3
|
1.08 hours
Interval 1.05 to 1.12
|
—
|
—
|
—
|
|
Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)
Cycle 1 Day 1
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.42 hours
Interval 0.42 to 0.42
|
1.89 hours
Interval 0.25 to 3.53
|
0.72 hours
Interval 0.72 to 0.72
|
0.78 hours
Interval 0.57 to 1.0
|
0.55 hours
Interval 0.53 to 0.67
|
0.53 hours
Interval 0.5 to 1.13
|
1.05 hours
Interval 0.58 to 1.52
|
1.05 hours
Interval 0.98 to 1.4
|
0.86 hours
Interval 0.58 to 1.07
|
1.40 hours
Interval 0.93 to 1.78
|
1.16 hours
Interval 1.02 to 1.3
|
—
|
—
|
—
|
|
Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)
Cycle 1 Day 15
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.17 hours
Interval 0.17 to 0.17
|
0.33 hours
Interval 0.33 to 0.33
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantitation
|
0.50 hours
Interval 0.5 to 0.5
|
0.50 hours
Interval 0.5 to 0.5
|
0.50 hours
Interval 0.5 to 0.5
|
1.00 hours
Interval 1.0 to 1.05
|
1.00 hours
Interval 1.0 to 3.0
|
1.00 hours
Interval 1.0 to 1.0
|
1.00 hours
Interval 1.0 to 1.25
|
1.00 hours
Interval 1.0 to 1.0
|
—
|
—
|
—
|
|
Time at Which Maximum Concentration of SL-279252 is Observed (Tmax)
Cycle 2 Day 1 (Schedule 2 only)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.70 hours
Interval 0.53 to 0.88
|
1.04 hours
Interval 1.02 to 1.08
|
1.03 hours
Interval 1.03 to 1.03
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
The AUC is the area under the serum concentration time curve following single and multiple doses of SL-279252. AUC (0-inf; from time 0 to infinity) is reported for C1D1 and C2D1 (Schedule 1 only); AUC (tau; over a dosing interval) is reported for C1D15 and C2D1 (Schedule 2 only).
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=8 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=12 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=9 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve (AUC)
Cycle 1 Day 1
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
56.6 hours*ng/mL
Geometric Coefficient of Variation 77.5
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
804 hours*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant (one participant's concentrations were below limit of quantitation)
|
2960 hours*ng/mL
Geometric Coefficient of Variation 40.1
|
10900 hours*ng/mL
Geometric Coefficient of Variation 39.2
|
38800 hours*ng/mL
Geometric Coefficient of Variation 32.7
|
110000 hours*ng/mL
Geometric Coefficient of Variation 52.9
|
353000 hours*ng/mL
Geometric Coefficient of Variation 29.4
|
1140000 hours*ng/mL
Geometric Coefficient of Variation 48.2
|
1380000 hours*ng/mL
Geometric Coefficient of Variation 22.4
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve (AUC)
Cycle 1 Day 15
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
68.8 hours*ng/mL
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
3410 hours*ng/mL
Geometric Coefficient of Variation 47.4
|
11600 hours*ng/mL
Geometric Coefficient of Variation 43.5
|
40800 hours*ng/mL
Geometric Coefficient of Variation 38.9
|
130000 hours*ng/mL
Geometric Coefficient of Variation 40.5
|
325000 hours*ng/mL
Geometric Coefficient of Variation 31.5
|
1100000 hours*ng/mL
Geometric Coefficient of Variation 21.2
|
1390000 hours*ng/mL
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve (AUC)
Cycle 2 Day 1 (Schedule 1 only)
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
—
|
NA hours*ng/mL
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
3240 hours*ng/mL
Geometric Coefficient of Variation 35.7
|
10800 hours*ng/mL
Geometric Coefficient of Variation 43.7
|
36800 hours*ng/mL
Geometric Coefficient of Variation 24.1
|
103000 hours*ng/mL
Geometric Coefficient of Variation 15.3
|
388000 hours*ng/mL
Geometric Coefficient of Variation 28.2
|
1160000 hours*ng/mL
Geometric Coefficient of Variation 29.7
|
1560000 hours*ng/mL
Geometric Coefficient of Variation 15.0
|
—
|
—
|
—
|
|
Area Under the Serum Concentration-time Curve (AUC)
Cycle 2 Day 1 (Schedule 2 only)
|
—
|
—
|
—
|
—
|
—
|
—
|
11500 hours*ng/mL
Geometric Coefficient of Variation 16.1
|
33600 hours*ng/mL
Geometric Coefficient of Variation 58.5
|
145000 hours*ng/mL
Geometric Coefficient of Variation 35.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis. Not estimable based on subjects' concentration profiles, including values below the limit of quantification
The t1/2 elimination half-life of SL-279252
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=8 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=12 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=9 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half Life (t1/2)
Cycle 1 Day 1
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
2.69 hours
Interval 2.69 to 2.69
|
4.36 hours
Interval 2.23 to 6.49
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
1.23 hours
Interval 1.23 to 1.23
|
25.2 hours
Interval 2.49 to 26.3
|
23.4 hours
Interval 17.0 to 29.1
|
22.6 hours
Interval 15.3 to 24.9
|
22.4 hours
Interval 19.4 to 36.3
|
22.9 hours
Interval 19.1 to 27.3
|
20.0 hours
Interval 12.9 to 22.4
|
14.4 hours
Interval 10.5 to 18.3
|
—
|
—
|
—
|
|
Terminal Half Life (t1/2)
Cycle 1 Day 15
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
5.74 hours
Interval 5.74 to 5.74
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
5.30 hours
Interval 5.17 to 5.43
|
5.87 hours
Interval 4.86 to 6.95
|
6.00 hours
Interval 3.06 to 7.05
|
6.14 hours
Interval 5.34 to 7.01
|
6.48 hours
Interval 5.73 to 7.31
|
4.86 hours
Interval 4.82 to 5.6
|
4.13 hours
Interval 3.99 to 4.26
|
—
|
—
|
—
|
|
Terminal Half Life (t1/2)
Cycle 2 Day 1 (Schedule 1 only)
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
—
|
NA hours
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
5.30 hours
Interval 3.1 to 5.51
|
5.22 hours
Interval 4.46 to 5.9
|
5.98 hours
Interval 5.7 to 6.56
|
5.48 hours
Interval 5.09 to 5.88
|
5.32 hours
Interval 4.64 to 6.0
|
4.71 hours
Interval 4.62 to 5.44
|
3.78 hours
Interval 3.34 to 4.23
|
—
|
—
|
—
|
|
Terminal Half Life (t1/2)
Cycle 2 Day 1 (Schedule 2 only)
|
—
|
—
|
—
|
—
|
—
|
—
|
4.48 hours
Interval 4.31 to 5.5
|
5.09 hours
Interval 2.33 to 5.8
|
5.10 hours
Interval 4.18 to 5.79
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
Clearance of SL-279252
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=8 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=12 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=9 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance
Cycle 2 Day 1 (Schedule 1 only)
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
—
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.0309 liters per hour per kg
Geometric Coefficient of Variation 35.7
|
0.0277 liters per hour per kg
Geometric Coefficient of Variation 43.7
|
0.0272 liters per hour per kg
Geometric Coefficient of Variation 24.1
|
0.0291 liters per hour per kg
Geometric Coefficient of Variation 15.3
|
0.0155 liters per hour per kg
Geometric Coefficient of Variation 28.2
|
0.0103 liters per hour per kg
Geometric Coefficient of Variation 29.7
|
0.0154 liters per hour per kg
Geometric Coefficient of Variation 15.0
|
—
|
—
|
—
|
|
Clearance
Cycle 1 Day 1
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.0530 liters per hour per kg
Geometric Coefficient of Variation 77.5
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.0373 liters per hour per kg
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant (one participant's concentrations were below limit of quantitation)
|
0.0338 liters per hour per kg
Geometric Coefficient of Variation 40.1
|
0.0274 liters per hour per kg
Geometric Coefficient of Variation 39.2
|
0.0258 liters per hour per kg
Geometric Coefficient of Variation 32.7
|
0.0272 liters per hour per kg
Geometric Coefficient of Variation 52.9
|
0.0170 liters per hour per kg
Geometric Coefficient of Variation 29.4
|
0.0106 liters per hour per kg
Geometric Coefficient of Variation 48.2
|
0.0174 liters per hour per kg
Geometric Coefficient of Variation 22.4
|
—
|
—
|
—
|
|
Clearance
Cycle 1 Day 15
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.0436 liters per hour per kg
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per hour per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.0293 liters per hour per kg
Geometric Coefficient of Variation 47.4
|
0.0258 liters per hour per kg
Geometric Coefficient of Variation 43.5
|
0.0245 liters per hour per kg
Geometric Coefficient of Variation 38.9
|
0.0231 liters per hour per kg
Geometric Coefficient of Variation 40.5
|
0.0184 liters per hour per kg
Geometric Coefficient of Variation 31.5
|
0.0109 liters per hour per kg
Geometric Coefficient of Variation 21.2
|
0.0172 liters per hour per kg
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
|
Clearance
Cycle 2 Day 1 (Schedule 2 only)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0261 liters per hour per kg
Geometric Coefficient of Variation 16.1
|
0.0298 liters per hour per kg
Geometric Coefficient of Variation 58.5
|
0.0207 liters per hour per kg
Geometric Coefficient of Variation 35.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (cycle = 28 days)Population: PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis.
Volume of distribution of SL-279252
Outcome measures
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 Participants
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 Participants
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 Participants
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 Participants
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 Participants
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 Participants
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=8 Participants
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=12 Participants
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=9 Participants
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 Participants
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 Participants
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 Participants
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution
Cycle 1 Day 1
|
NA liters per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.291 liters per kg
Geometric Coefficient of Variation 6.92
|
NA liters per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.0664 liters per kg
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation not calculable for a single participant (one participant's concentrations were below limit of quantitation)
|
0.576 liters per kg
Geometric Coefficient of Variation 144
|
0.894 liters per kg
Geometric Coefficient of Variation 38.0
|
0.797 liters per kg
Geometric Coefficient of Variation 31.8
|
0.939 liters per kg
Geometric Coefficient of Variation 52.8
|
0.562 liters per kg
Geometric Coefficient of Variation 33.8
|
0.281 liters per kg
Geometric Coefficient of Variation 64.8
|
0.348 liters per kg
Geometric Coefficient of Variation 17.4
|
—
|
—
|
—
|
|
Volume of Distribution
Cycle 2 Day 1 (Schedule 1 only)
|
NA liters per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
NA liters per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
—
|
NA liters per kg
Geometric Coefficient of Variation NA
Not estimable based on subjects' concentration profiles, including values below the limit of quantification
|
0.200 liters per kg
Geometric Coefficient of Variation 46.3
|
0.207 liters per kg
Geometric Coefficient of Variation 37.1
|
0.237 liters per kg
Geometric Coefficient of Variation 23.7
|
0.229 liters per kg
Geometric Coefficient of Variation 12.5
|
0.118 liters per kg
Geometric Coefficient of Variation 9.5
|
0.0730 liters per kg
Geometric Coefficient of Variation 20.5
|
0.0834 liters per kg
Geometric Coefficient of Variation 32.3
|
—
|
—
|
—
|
|
Volume of Distribution
Cycle 2 Day 1 (Schedule 2 only)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.178 liters per kg
Geometric Coefficient of Variation 8.63
|
0.189 liters per kg
Geometric Coefficient of Variation 30.4
|
0.149 liters per kg
Geometric Coefficient of Variation 47.1
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SL-279252 (0.0001 mg/kg S1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
SL-279252 (0.001 mg/kg S1)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
SL-279252 (0.003 mg/kg S1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
SL-279252 (0.01 mg/kg S1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
SL-279252 (0.03 mg/kg S1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SL-279252 (0.1 mg/kg S1)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
SL-279252 (0.3 mg/kg S1)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
SL-279252 (1.0 mg/kg S1)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
SL-279252 (3.0 mg/kg S1)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 5 deaths
SL-279252 (6.0 mg/kg S1)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 4 deaths
SL-279252 (12.0 mg/kg S1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
SL-279252 (24.0 mg/kg S1)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
SL-279252 (0.3 mg/kg S2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
SL-279252 (1.0 mg/kg S2)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
SL-279252 (3.0 mg/kg S2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 participants at risk
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 participants at risk
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 participants at risk
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 participants at risk
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 participants at risk
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 participants at risk
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=4 participants at risk
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=6 participants at risk
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=6 participants at risk
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 participants at risk
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 participants at risk
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 participants at risk
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
n=4 participants at risk
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
n=6 participants at risk
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
n=3 participants at risk
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
acetabulum fracture
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
diffuse large B-cell lymphoma
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
haemorrhage intracranial
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
hemiparesis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
infected neoplasm
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
inguinal hernia, obstructive
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
mouth haemorrhage
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory tract infection
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
seizure
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
asthenia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Hepatobiliary disorders
cholecystitis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
subarachnoid haemorrhage
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Number of events 1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
Other adverse events
| Measure |
SL-279252 (0.0001 mg/kg S1)
n=1 participants at risk
0.0001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.001 mg/kg S1)
n=1 participants at risk
0.001 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.003 mg/kg S1)
n=2 participants at risk
0.003 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.01 mg/kg S1)
n=1 participants at risk
0.01 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.03 mg/kg S1)
n=2 participants at risk
0.03 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.1 mg/kg S1)
n=3 participants at risk
0.1 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S1)
n=4 participants at risk
0.3 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (1.0 mg/kg S1)
n=6 participants at risk
1.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (3.0 mg/kg S1)
n=6 participants at risk
3.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (6.0 mg/kg S1)
n=4 participants at risk
6.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (12.0 mg/kg S1)
n=4 participants at risk
12.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (24.0 mg/kg S1)
n=2 participants at risk
24.0 mg/kg of IV SL-279252 (Schedule 1)
|
SL-279252 (0.3 mg/kg S2)
n=4 participants at risk
0.3 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (1.0 mg/kg S2)
n=6 participants at risk
1.0 mg/kg of IV SL-279252 (Schedule 2)
|
SL-279252 (3.0 mg/kg S2)
n=3 participants at risk
3.0 mg/kg of IV SL-279252 (Schedule 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
sacral pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
constipation
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
3/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
decreased appetite
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Injury, poisoning and procedural complications
infusion related reaction
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
66.7%
2/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Psychiatric disorders
insomnia
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
fatigue
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
dehydration
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
dizziness
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
headache
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
asthenia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
2/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
non-cardiac chest pain
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
66.7%
2/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
2/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Vascular disorders
hypotension
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Endocrine disorders
hypothyroidism
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
2/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hypercalcaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Vascular disorders
hypertension
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hyponatraemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
influenza like illness
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
neuropathy peripheral
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Skin and subcutaneous tissue disorders
night sweats
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
pyrexia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
seizure
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
anorectal discomfort
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
faeces discoloured
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
haematochezia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
large intestinal haemorrhage
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
odynophagia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
rectal haemorrhage
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
stomatitis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
chest pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
chills
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
face oedema
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
gait disturbance
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
localised oedema
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
oedema peripheral
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
General disorders
peripheral swelling
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hyperphosphataemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
anosmia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
dyskinesia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Nervous system disorders
paraesthesia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
100.0%
1/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary congestion
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
rhonci
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
thoracic haemorrhage
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Blood and lymphatic system disorders
thrombocytosis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Skin and subcutaneous tissue disorders
skin lesion
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Injury, poisoning and procedural complications
corneal abrasion
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Infections and infestations
oral candidiasis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Infections and infestations
pneumonia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Infections and infestations
respiratory tract infection
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Infections and infestations
sinusitis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Psychiatric disorders
delirium
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Vascular disorders
flushing
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Renal and urinary disorders
haematuria
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Renal and urinary disorders
nocturia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Renal and urinary disorders
pollakiuria
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Endocrine disorders
adrenal insufficiency
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Investigations
blood creatinine increased
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Investigations
blood iron decreased
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Investigations
weight decreased
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
33.3%
1/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Reproductive system and breast disorders
breast pain
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
50.0%
1/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Reproductive system and breast disorders
vaginal haemorrhage
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Eye disorders
eyelid function disorder
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Hepatobiliary disorders
hyperbilirubinaemia
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
16.7%
1/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
|
Investigations
blood creatine increased
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/1 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
25.0%
1/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/2 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/4 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/6 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
0.00%
0/3 • Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 17 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site agrees not to publish any Study Results or data before the publication of results from the Overall Study. After Sponsor has published the results of the Overall Study, Site may publish or present results generated at Site. If Sponsor has not published results of the Overall Study within 18 months of data base lock, Site may publish the results of the Study that were generated at Site. Site agrees to first submit to Sponsor the proposed publication at least 30 days prior to the submission.
- Publication restrictions are in place
Restriction type: OTHER