Trial Outcomes & Findings for An Ascending Dose Study of KW-2449 in Acute Leukemias, Myelodysplastic Syndromes, and Chronic Myelogenous Leukemia (NCT NCT00346632)
NCT ID: NCT00346632
Last Updated: 2024-05-17
Results Overview
In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Baseline up to Cycle 2, Day 1
Results posted on
2024-05-17
Participant Flow
Four study centers in the US
Participant milestones
| Measure |
25 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
50 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
100 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
200 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
300 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
400 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
500 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
25 mg/Day KW-2449 28-day Regimen (Arm B)
Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
|
50 mg/Day KW-2449 28-day Regimen (Arm B)
Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
|
100 mg/Day KW-2449 28-day Regimen (Arm B)
Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
4
|
2
|
5
|
4
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
3
|
4
|
2
|
5
|
4
|
4
|
3
|
Reasons for withdrawal
| Measure |
25 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
50 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
100 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
200 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
300 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
400 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
500 mg/Day KW-2449 14-day Regimen (Arm A)
Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
|
25 mg/Day KW-2449 28-day Regimen (Arm B)
Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
|
50 mg/Day KW-2449 28-day Regimen (Arm B)
Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
|
100 mg/Day KW-2449 28-day Regimen (Arm B)
Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
2
|
2
|
4
|
3
|
3
|
1
|
2
|
2
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Switched to alternative treatment
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Not Stated
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
Baseline Characteristics
An Ascending Dose Study of KW-2449 in Acute Leukemias, Myelodysplastic Syndromes, and Chronic Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Arm A: KW-2449 14-day Regimen
n=26 Participants
Sequential ascending oral doses of KW-2449 given for 14-day cycles
|
Arm B: KW-2449 28-day Regimen
n=11 Participants
Sequential ascending oral doses of KW-2449 given for 28-day cycles
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 15.48 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 17.22 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
11 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Cycle 2, Day 1In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.
Outcome measures
| Measure |
Arm A - 25 mg/Day
n=3 Participants
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 Participants
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=6 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 Participants
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=4 Participants
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=2 Participants
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=26 Participants
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=11 Participants
Total Patients in Treatment Arm B
|
Arm A - 500 mg/Day: Day 1
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day: Day 14
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm B - 25 mg/Day: Day 1
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 14
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 28
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 1
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 14
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 28
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg.Day: Day 1
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm B - 100 mg/Day: Day 14
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day: Day 28
KW2449-001 100 mg/day (Treatment Arm B)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
Subjects with any TEAE
|
3 participants
|
3 participants
|
6 participants
|
3 participants
|
4 participants
|
2 participants
|
5 participants
|
26 participants
|
4 participants
|
4 participants
|
3 participants
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
Subjects with any serious TEAE
|
2 participants
|
2 participants
|
5 participants
|
2 participants
|
4 participants
|
1 participants
|
3 participants
|
19 participants
|
2 participants
|
3 participants
|
3 participants
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
Subjects with TEAE related to study drug
|
1 participants
|
3 participants
|
6 participants
|
3 participants
|
4 participants
|
2 participants
|
3 participants
|
22 participants
|
3 participants
|
3 participants
|
3 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
Subjects with TEAE of Grade 3 or above
|
2 participants
|
2 participants
|
6 participants
|
2 participants
|
4 participants
|
2 participants
|
3 participants
|
21 participants
|
1 participants
|
3 participants
|
3 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
Subjects who discontinued the study due to TEA
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0
Subjects who died
|
1 participants
|
0 participants
|
5 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
11 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1Outcome measures
| Measure |
Arm A - 25 mg/Day
n=3 Participants
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 Participants
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 Participants
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=6 Participants
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=6 Participants
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=3 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=3 Participants
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=2 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=2 Participants
Total Patients in Treatment Arm B
|
Arm A - 500 mg/Day: Day 1
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day: Day 14
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm B - 25 mg/Day: Day 1
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 14
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 28
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 1
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 14
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 28
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg.Day: Day 1
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm B - 100 mg/Day: Day 14
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day: Day 28
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Observed Peak Plasma Concentration (Cmax)
|
6.35 ng/mL
Standard Deviation 0.754
|
7.94 ng/mL
Standard Deviation 3.06
|
10.5 ng/mL
Standard Deviation 3.49
|
18.6 ng/mL
Standard Deviation 3.10
|
34.4 ng/mL
Standard Deviation 15.7
|
38.8 ng/mL
Standard Deviation 16.1
|
31.3 ng/mL
Standard Deviation 17.8
|
83.7 ng/mL
Standard Deviation 97.4
|
97.5 ng/mL
Standard Deviation 18.6
|
147 ng/mL
Standard Deviation 77.1
|
151 ng/mL
Standard Deviation 52.3
|
198 ng/mL
Standard Deviation 23.3
|
180 ng/mL
Standard Deviation 125
|
371 ng/mL
Standard Deviation 129
|
7.05 ng/mL
Standard Deviation 4.85
|
8.39 ng/mL
Standard Deviation 1.70
|
4.49 ng/mL
Standard Deviation 1.97
|
8.20 ng/mL
Standard Deviation 4.11
|
12.7 ng/mL
Standard Deviation 4.73
|
15.6 ng/mL
Standard Deviation 9.43
|
20.9 ng/mL
Standard Deviation 9.66
|
36.3 ng/mL
Standard Deviation 15.1
|
32.5 ng/mL
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1Outcome measures
| Measure |
Arm A - 25 mg/Day
n=3 Participants
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 Participants
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 Participants
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=6 Participants
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=6 Participants
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=3 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=3 Participants
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=2 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=2 Participants
Total Patients in Treatment Arm B
|
Arm A - 500 mg/Day: Day 1
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day: Day 14
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm B - 25 mg/Day: Day 1
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 14
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 28
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 1
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 14
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 28
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg.Day: Day 1
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm B - 100 mg/Day: Day 14
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day: Day 28
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Peak Plasma Concentration (Tmax)
|
1.51 hours
Standard Deviation 0.508
|
1.83 hours
Standard Deviation 1.18
|
1.67 hours
Standard Deviation 0.577
|
2.06 hours
Standard Deviation 0.0962
|
1.31 hours
Standard Deviation 0.386
|
0.979 hours
Standard Deviation 0.728
|
2.97 hours
Standard Deviation 1.71
|
2.68 hours
Standard Deviation 1.36
|
1.67 hours
Standard Deviation 0.577
|
1.50 hours
Standard Deviation 0.707
|
2.00 hours
Standard Deviation 0.00
|
1.57 hours
Standard Deviation 0.613
|
2.27 hours
Standard Deviation 1.23
|
1.50 hours
Standard Deviation 0.707
|
2.27 hours
Standard Deviation 1.28
|
1.14 hours
Standard Deviation 0.177
|
1.33 hours
Standard Deviation 0.583
|
1.26 hours
Standard Deviation 0.506
|
1.26 hours
Standard Deviation 0.492
|
1.44 hours
Standard Deviation 0.509
|
1.34 hours
Standard Deviation 0.587
|
2.00 hours
Standard Deviation 1.73
|
1.54 hours
Standard Deviation 0.766
|
SECONDARY outcome
Timeframe: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1Outcome measures
| Measure |
Arm A - 25 mg/Day
n=3 Participants
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 Participants
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 Participants
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=6 Participants
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=6 Participants
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=3 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=3 Participants
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=2 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=2 Participants
Total Patients in Treatment Arm B
|
Arm A - 500 mg/Day: Day 1
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day: Day 14
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm B - 25 mg/Day: Day 1
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 14
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 28
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 1
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 14
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 28
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg.Day: Day 1
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm B - 100 mg/Day: Day 14
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day: Day 28
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))
|
23.6 hr*ng/mL
Standard Deviation 8.56
|
30.9 hr*ng/mL
Standard Deviation NA
Data cannot be located. Study completed in 2008 and none of the people who worked on the study are still with the company
|
46.7 hr*ng/mL
Standard Deviation 11.1
|
77.9 hr*ng/mL
Standard Deviation 29.7
|
138 hr*ng/mL
Standard Deviation 41.8
|
162 hr*ng/mL
Standard Deviation 28.7
|
173 hr*ng/mL
Standard Deviation 90.5
|
647 hr*ng/mL
Standard Deviation 665
|
428 hr*ng/mL
Standard Deviation 192
|
626 hr*ng/mL
Standard Deviation 310
|
647 hr*ng/mL
Standard Deviation 73.5
|
1060 hr*ng/mL
Standard Deviation 300
|
822 hr*ng/mL
Standard Deviation 463
|
1200 hr*ng/mL
Standard Deviation 180
|
38.0 hr*ng/mL
Standard Deviation 18.0
|
35.3 hr*ng/mL
Standard Deviation 8.76
|
28.8 hr*ng/mL
Standard Deviation 7.36
|
36.3 hr*ng/mL
Standard Deviation 18.1
|
58.7 hr*ng/mL
Standard Deviation 21.7
|
60.3 hr*ng/mL
Standard Deviation 23.6
|
107 hr*ng/mL
Standard Deviation 31.2
|
158 hr*ng/mL
Standard Deviation 58.8
|
147 hr*ng/mL
Standard Deviation 90.9
|
SECONDARY outcome
Timeframe: Days 1 and 14 (and Day 28 for Arm B) of Cycle 1Outcome measures
| Measure |
Arm A - 25 mg/Day
n=3 Participants
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 Participants
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 Participants
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=6 Participants
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=6 Participants
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=3 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=3 Participants
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=2 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=2 Participants
Total Patients in Treatment Arm B
|
Arm A - 500 mg/Day: Day 1
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day: Day 14
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm B - 25 mg/Day: Day 1
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 14
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 28
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 1
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 14
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 28
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg.Day: Day 1
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm B - 100 mg/Day: Day 14
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day: Day 28
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half Life (t 1/2)
|
2.96 hours
Standard Deviation 1.42
|
3.36 hours
Standard Deviation NA
Data cannot be located. Study completed in 2008 and none of the people who worked on the study are still with the company
|
2.67 hours
Standard Deviation 0.435
|
3.26 hours
Standard Deviation 0.631
|
3.11 hours
Standard Deviation 0.310
|
2.80 hours
Standard Deviation 0.187
|
3.27 hours
Standard Deviation NA
Data cannot be located. Study completed in 2008 and none of the people who worked on the study are still with the company
|
3.04 hours
Standard Deviation 0.715
|
2.48 hours
Standard Deviation 0.158
|
2.44 hours
Standard Deviation 0.149
|
2.42 hours
Standard Deviation 0.06
|
2.83 hours
Standard Deviation 0.0806
|
2.93 hours
Standard Deviation 1.01
|
2.47 hours
Standard Deviation 0.105
|
2.78 hours
Standard Deviation 0.108
|
3.00 hours
Standard Deviation 0.453
|
3.35 hours
Standard Deviation 0.443
|
3.90 hours
Standard Deviation 1.43
|
3.32 hours
Standard Deviation 0.383
|
3.88 hours
Standard Deviation 1.64
|
2.97 hours
Standard Deviation 0.471
|
3.90 hours
Standard Deviation 1.62
|
3.16 hours
Standard Deviation NA
Data cannot be located. Study completed in 2008 and none of the people who worked on the study are still with the company
|
SECONDARY outcome
Timeframe: Day 1 and either Day 14 or Day 28 of Cycle 1Outcome measures
| Measure |
Arm A - 25 mg/Day
n=3 Participants
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 Participants
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=6 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 Participants
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=4 Participants
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=2 Participants
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=4 Participants
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=4 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=3 Participants
Total Patients in Treatment Arm B
|
Arm A - 500 mg/Day: Day 1
n=3 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day: Day 14
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm B - 25 mg/Day: Day 1
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 14
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 28
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 1
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 14
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 28
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg.Day: Day 1
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm B - 100 mg/Day: Day 14
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day: Day 28
KW2449-001 100 mg/day (Treatment Arm B)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)
|
1.50 Ratio of hr*ng/mL
Standard Deviation NA
Data cannot be located. Study completed in 2008 and none of the people who worked on the study are still with the company
|
1.66 Ratio of hr*ng/mL
Standard Deviation 0.389
|
1.50 Ratio of hr*ng/mL
Standard Deviation 0.459
|
3.37 Ratio of hr*ng/mL
Standard Deviation 1.45
|
1.28 Ratio of hr*ng/mL
Standard Deviation 0.0271
|
1.68 Ratio of hr*ng/mL
Standard Deviation 0.654
|
0.846 Ratio of hr*ng/mL
Standard Deviation NA
Data cannot be located. Study completed in 2008 and none of the people who worked on the study are still with the company
|
0.953 Ratio of hr*ng/mL
Standard Deviation 0.181
|
0.906 Ratio of hr*ng/mL
Standard Deviation 0.622
|
1.42 Ratio of hr*ng/mL
Standard Deviation 0.331
|
1.44 Ratio of hr*ng/mL
Standard Deviation 0.180
|
1.50 Ratio of hr*ng/mL
Standard Deviation 0.187
|
1.60 Ratio of hr*ng/mL
Standard Deviation NA
Data cannot be located. Study completed in 2008 and none of the people who worked on the study are still with the company
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14 (Arm A) or Day 28 (Arm B) for all cyclesDisease response (i.e., complete or partial remission) based on standard criteria: Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649. Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674. VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) \[updated March 2002; cited 2005 Nov 16\]. Available from: http://www.pbm.va.gov/archive/imatinibcriteria.pdf
Outcome measures
| Measure |
Arm A - 25 mg/Day
n=3 Participants
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 Participants
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=6 Participants
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 Participants
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=4 Participants
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=2 Participants
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=5 Participants
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=26 Participants
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 Participants
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 Participants
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=3 Participants
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=11 Participants
Total Patients in Treatment Arm B
|
Arm A - 500 mg/Day: Day 1
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day: Day 14
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm B - 25 mg/Day: Day 1
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 14
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 25 mg/Day: Day 28
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 1
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 14
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day: Day 28
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg.Day: Day 1
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm B - 100 mg/Day: Day 14
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day: Day 28
KW2449-001 100 mg/day (Treatment Arm B)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Response
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
0 number of responders
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm A - 25 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A - 50 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A - 100 mg/Day
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm A - 200 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A - 300 mg/Day
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm A - 400 mg/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm A - 500 mg/Day
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm A - Total
Serious events: 19 serious events
Other events: 26 other events
Deaths: 0 deaths
Arm B - 25 mg/Day
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B - 50 mg/Day
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B - 100 mg/Day
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B - Total
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - 25 mg/Day
n=3 participants at risk
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 participants at risk
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=6 participants at risk
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 participants at risk
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=4 participants at risk
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=2 participants at risk
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=5 participants at risk
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=26 participants at risk
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 participants at risk
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 participants at risk
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=3 participants at risk
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=11 participants at risk
Total Patients in Treatment Arm B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
40.0%
2/5 • Number of events 2
|
30.8%
8/26 • Number of events 8
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Catheter related complication
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Death
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Disease progression
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
15.4%
4/26 • Number of events 4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Localised infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
15.4%
4/26 • Number of events 5
|
0.00%
0/4
|
75.0%
3/4 • Number of events 3
|
0.00%
0/3
|
27.3%
3/11 • Number of events 3
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
Other adverse events
| Measure |
Arm A - 25 mg/Day
n=3 participants at risk
KW2449-001 25 mg/day (Treatment Arm A)
|
Arm A - 50 mg/Day
n=3 participants at risk
KW2449-001 50 mg/day (Treatment Arm A)
|
Arm A - 100 mg/Day
n=6 participants at risk
KW2449-001 100 mg/day (Treatment Arm A)
|
Arm A - 200 mg/Day
n=3 participants at risk
KW2449-001 200 mg/day (Treatment Arm A)
|
Arm A - 300 mg/Day
n=4 participants at risk
KW2449-001 300 mg/day (Treatment Arm A)
|
Arm A - 400 mg/Day
n=2 participants at risk
KW2449-001 400 mg/day (Treatment Arm A)
|
Arm A - 500 mg/Day
n=5 participants at risk
KW2449-001 500 mg/day (Treatment Arm A)
|
Arm A - Total
n=26 participants at risk
Total Patients in Treatment Arm A
|
Arm B - 25 mg/Day
n=4 participants at risk
KW2449-001 25 mg/day (Treatment Arm B)
|
Arm B - 50 mg/Day
n=4 participants at risk
KW2449-001 50 mg/day (Treatment Arm B)
|
Arm B - 100 mg/Day
n=3 participants at risk
KW2449-001 100 mg/day (Treatment Arm B)
|
Arm B - Total
n=11 participants at risk
Total Patients in Treatment Arm B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood magnesium decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 5
|
33.3%
2/6 • Number of events 4
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
11.5%
3/26 • Number of events 9
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Congenital, familial and genetic disorders
Congenital jaw malformation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Dry eye
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Eye pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Macular degeneration
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Pupillary reflex impaired
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Scleral discolouration
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Eye disorders
Visual disturbance
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
25.0%
1/4 • Number of events 4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
19.2%
5/26 • Number of events 11
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
66.7%
2/3 • Number of events 3
|
0.00%
0/4
|
100.0%
2/2 • Number of events 2
|
0.00%
0/5
|
19.2%
5/26 • Number of events 6
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
75.0%
3/4 • Number of events 3
|
50.0%
1/2 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
30.8%
8/26 • Number of events 10
|
25.0%
1/4 • Number of events 2
|
50.0%
2/4 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
45.5%
5/11 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
18.2%
2/11 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
75.0%
3/4 • Number of events 7
|
50.0%
1/2 • Number of events 1
|
60.0%
3/5 • Number of events 3
|
65.4%
17/26 • Number of events 21
|
25.0%
1/4 • Number of events 2
|
50.0%
2/4 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
45.5%
5/11 • Number of events 7
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Oral mucosal petechiae
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 4
|
50.0%
2/4 • Number of events 2
|
100.0%
2/2 • Number of events 3
|
40.0%
2/5 • Number of events 3
|
53.8%
14/26 • Number of events 19
|
25.0%
1/4 • Number of events 1
|
50.0%
2/4 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
36.4%
4/11 • Number of events 5
|
|
General disorders
Asthenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 4
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Catheter site bruise
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Catheter site oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Catheter site pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Catheter site related reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/3
|
66.7%
2/3 • Number of events 4
|
66.7%
4/6 • Number of events 4
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
42.3%
11/26 • Number of events 14
|
50.0%
2/4 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
66.7%
2/3 • Number of events 6
|
45.5%
5/11 • Number of events 11
|
|
General disorders
Gait disturbance
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Injection site reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Local swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Localised oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Malaise
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Mucosa vesicle
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Nodule
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Oedema
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
19.2%
5/26 • Number of events 5
|
25.0%
1/4 • Number of events 2
|
50.0%
2/4 • Number of events 5
|
66.7%
2/3 • Number of events 3
|
45.5%
5/11 • Number of events 10
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
40.0%
2/5 • Number of events 4
|
19.2%
5/26 • Number of events 7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 3
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Otitis externa
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Subcutaneous abscess
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 3
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Investigations
Blood glucose increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Investigations
Cardiac murmur
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Electrocardiogram ST-T change
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Full blood count decreased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Investigations
Heart sounds abnormal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Investigations
Spleen palpable
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Sputum abnormal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Investigations
Troponin increased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
15.4%
4/26 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
50.0%
2/4 • Number of events 3
|
0.00%
0/3
|
27.3%
3/11 • Number of events 4
|
|
Metabolism and nutrition disorders
Appetite disorder
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
23.1%
6/26 • Number of events 9
|
0.00%
0/4
|
0.00%
0/4
|
66.7%
2/3 • Number of events 2
|
18.2%
2/11 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
11.5%
3/26 • Number of events 3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
100.0%
2/2 • Number of events 4
|
20.0%
1/5 • Number of events 1
|
23.1%
6/26 • Number of events 10
|
75.0%
3/4 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
36.4%
4/11 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
15.4%
4/26 • Number of events 4
|
0.00%
0/4
|
50.0%
2/4 • Number of events 3
|
0.00%
0/3
|
18.2%
2/11 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
0.00%
0/5
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
30.8%
8/26 • Number of events 8
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
15.4%
4/26 • Number of events 4
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
9.1%
1/11 • Number of events 2
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
11.5%
3/26 • Number of events 4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Drooling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
19.2%
5/26 • Number of events 6
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
9.1%
1/11 • Number of events 2
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
9.1%
1/11 • Number of events 2
|
|
Nervous system disorders
Sensory disturbance
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Sinus headache
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Nervous system disorders
Unresponsive to verbal stimuli
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Psychiatric disorders
Depressed mood
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
19.2%
5/26 • Number of events 6
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 4
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
26.9%
7/26 • Number of events 9
|
50.0%
2/4 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 3
|
36.4%
4/11 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
0.00%
0/3
|
27.3%
3/11 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
11.5%
3/26 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3
|
33.3%
1/3 • Number of events 4
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 4
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
36.4%
4/11 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
11.5%
3/26 • Number of events 4
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
40.0%
2/5 • Number of events 2
|
11.5%
3/26 • Number of events 3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/26
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/2
|
0.00%
0/5
|
3.8%
1/26 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
15.4%
4/26 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/2
|
0.00%
0/5
|
7.7%
2/26 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/11
|
Additional Information
Project Leader
Kyowa Kirin Pharmaceutical Development, Inc.
Phone: 6099191100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER