Trial Outcomes & Findings for Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function (NCT NCT00652626)
NCT ID: NCT00652626
Last Updated: 2019-11-19
Results Overview
Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
Azacitidine 25 mg/m^2
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Phase
STARTED
|
5
|
5
|
7
|
6
|
8
|
0
|
0
|
|
Initial Treatment Phase
Received Study Drug
|
5
|
5
|
6
|
5
|
6
|
0
|
0
|
|
Initial Treatment Phase
COMPLETED
|
5
|
5
|
6
|
5
|
5
|
0
|
0
|
|
Initial Treatment Phase
NOT COMPLETED
|
0
|
0
|
1
|
1
|
3
|
0
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
0
|
0
|
0
|
14
|
4
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
12
|
3
|
Reasons for withdrawal
| Measure |
Azacitidine 25 mg/m^2
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Initial Treatment Phase
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Initial Treatment Phase
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Initial Treatment Phase
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Initial Treatment Phase
Sponsor Request
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Treatment Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Extension Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Extension Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Extension Phase
No Longer Receiving Clinical Benefit
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Extension Phase
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Extension Phase
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function
Baseline characteristics by cohort
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
n=6 Participants
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
n=14 Participants
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
n=4 Participants
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Initial Treatment Period
|
67.6 years
STANDARD_DEVIATION 3.78 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 12.02 • n=4 Participants
|
74.5 years
STANDARD_DEVIATION 12.58 • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=10 Participants
|
NA years
STANDARD_DEVIATION NA • n=115 Participants
|
63.5 years
STANDARD_DEVIATION 12.32 • n=24 Participants
|
|
Age, Continuous
Extension Treatment Period
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
60.6 years
STANDARD_DEVIATION 9.52 • n=10 Participants
|
68.8 years
STANDARD_DEVIATION 11.0 • n=115 Participants
|
62.4 years
STANDARD_DEVIATION 10.15 • n=24 Participants
|
|
Sex/Gender, Customized
Female
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
16 participants
n=24 Participants
|
|
Sex/Gender, Customized
Male
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
11 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
8 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
19 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
27 participants
n=24 Participants
|
|
Gender of Extension Period Participants
Female
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
8 participants
n=10 Participants
|
2 participants
n=115 Participants
|
10 participants
n=24 Participants
|
|
Gender of Extension Period Participants
Male
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
6 participants
n=10 Participants
|
2 participants
n=115 Participants
|
8 participants
n=24 Participants
|
|
Race: Extension Phase
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
5 participants
n=10 Participants
|
0 participants
n=115 Participants
|
5 participants
n=24 Participants
|
|
Race: Extension Phase
White
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
9 participants
n=10 Participants
|
4 participants
n=115 Participants
|
13 participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status: Initial Treatment Phase
0
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
7 participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status: Initial Treatment Phase
1
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
18 participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status: Initial Treatment Phase
2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
2 participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status: Extension Phase
0
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
1 participants
n=115 Participants
|
3 participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status: Extension Phase
1
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
11 participants
n=10 Participants
|
3 participants
n=115 Participants
|
14 participants
n=24 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status: Extension Phase
2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Body Surface Area (BSA)
Initial Treatment Period
|
2.0 m^2
STANDARD_DEVIATION 0.20 • n=5 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.28 • n=7 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.42 • n=5 Participants
|
1.6 m^2
STANDARD_DEVIATION 0.15 • n=4 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.15 • n=21 Participants
|
NA m^2
STANDARD_DEVIATION NA • n=10 Participants
|
NA m^2
STANDARD_DEVIATION NA • n=115 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.27 • n=24 Participants
|
|
Body Surface Area (BSA)
Extension Period
|
NA m^2
STANDARD_DEVIATION NA • n=5 Participants
|
NA m^2
STANDARD_DEVIATION NA • n=7 Participants
|
NA m^2
STANDARD_DEVIATION NA • n=5 Participants
|
NA m^2
STANDARD_DEVIATION NA • n=4 Participants
|
NA m^2
STANDARD_DEVIATION NA • n=21 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.35 • n=10 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.06 • n=115 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.31 • n=24 Participants
|
|
Cancer Diagnosis: Initial Treatment Phase
Myelodysplastic syndrome-RA
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
2 participants
n=24 Participants
|
|
Cancer Diagnosis: Initial Treatment Phase
Myelodysplastic syndrome-RARS
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Cancer Diagnosis: Initial Treatment Phase
Myelodysplastic syndrome-RAEB-T
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
2 participants
n=24 Participants
|
|
Cancer Diagnosis: Initial Treatment Phase
Chronic myelomonocytic leukemia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Cancer Diagnosis: Initial Treatment Phase
Solid tumor
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
20 participants
n=24 Participants
|
|
Cancer Diagnosis: Initial Treatment Phase
Multiple myeloma
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Cancer Diagnosis: Extension Phase
Myelodysplastic syndrome-RA
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Cancer Diagnosis: Extension Phase
Myelodysplastic syndrome-RARS
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Cancer Diagnosis: Extension Phase
Myelodysplastic syndrome-RAEB-T
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
|
Cancer Diagnosis: Extension Phase
Chronic myelomonocytic leukemia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
|
Cancer Diagnosis: Extension Phase
Solid tumor
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
12 participants
n=10 Participants
|
3 participants
n=115 Participants
|
15 participants
n=24 Participants
|
|
Cancer Diagnosis: Extension Phase
Multiple myeloma
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose
|
455.86 ng*hr/mL
Geometric Coefficient of Variation 26.04
|
897.43 ng*hr/mL
Geometric Coefficient of Variation 31.00
|
921.87 ng*hr/mL
Geometric Coefficient of Variation 39.215
|
1502.86 ng*hr/mL
Geometric Coefficient of Variation 25.57
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point
|
454.80 ng*hr/mL
Geometric Coefficient of Variation 26.22
|
895.38 ng*hr/mL
Geometric Coefficient of Variation 31.20
|
920.76 ng*hr/mL
Geometric Coefficient of Variation 39.20
|
1505.16 ng*hr/mL
Geometric Coefficient of Variation 25.57
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine after a single dose, calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation: AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
|
460.47 ng*hr/mL
Geometric Coefficient of Variation 25.79
|
897.42 ng*hr/mL
Geometric Coefficient of Variation 30.93
|
945.50 ng*hr/mL
Geometric Coefficient of Variation 39.05
|
1533.37 ng*hr/mL
Geometric Coefficient of Variation 23.96
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
The maximum observed plasma concentration of azacitidine after a single dose on Day 1.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Azacitidine (Cmax)
|
293.38 ng/mL
Geometric Coefficient of Variation 34.11
|
749.04 ng/mL
Geometric Coefficient of Variation 61.03
|
745.50 ng/mL
Geometric Coefficient of Variation 57.90
|
1261.96 ng/mL
Geometric Coefficient of Variation 39.19
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
The time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration of Azacitidine (Tmax)
|
0.25 hours
Interval 0.25 to 1.0
|
0.25 hours
Interval 0.25 to 0.78
|
0.25 hours
Interval 0.25 to 0.5
|
0.27 hours
Interval 0.25 to 0.75
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
The terminal phase half-life of azacitidine after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Terminal Phase Half-life of Azacitidine (t½)
|
1.38 hours
Geometric Coefficient of Variation 27.31
|
0.63 hours
Geometric Coefficient of Variation 35.72
|
1.19 hours
Geometric Coefficient of Variation 102.56
|
1.03 hours
Geometric Coefficient of Variation 78.48
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
The apparent total clearance of azacitidine after a single dose on Day 1, calculated as Dose/AUC0-inf.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Apparent Total Clearance of Azacitidine (CL/F)
|
104.58 liters/hour
Geometric Coefficient of Variation 25.00
|
105.76 liters/hour
Geometric Coefficient of Variation 17.03
|
151.55 liters/hour
Geometric Coefficient of Variation 30.88
|
106.00 liters/hour
Geometric Coefficient of Variation 25.64
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz)
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution of Azacitidine (Vz/F)
|
208.69 liters
Geometric Coefficient of Variation 45.57
|
96.74 liters
Geometric Coefficient of Variation 36.75
|
259.44 liters
Geometric Coefficient of Variation 121.71
|
456.69 liters
Geometric Coefficient of Variation 99.41
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function. Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine
Day 1
|
921.87 ng*hr/mL
Geometric Coefficient of Variation 39.15
|
1558.32 ng*hr/mL
Geometric Coefficient of Variation 64.95
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine
Day 5
|
843.03 ng*hr/mL
Geometric Coefficient of Variation 12.00
|
1183.61 ng*hr/mL
Geometric Coefficient of Variation 51.92
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule for participants with normal renal function and for participants with severe renal impairment.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine
Day 1
|
920.76 ng*hr/mL
Geometric Coefficient of Variation 39.20
|
1558.72 ng*hr/mL
Geometric Coefficient of Variation 65.02
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine
Day 5
|
841.62 ng*hr/mL
Geometric Coefficient of Variation 11.83
|
1181.83 ng*hr/mL
Geometric Coefficient of Variation 51.98
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation: AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine
Day 1
|
946.22 ng*hr/mL
Geometric Coefficient of Variation 39.05
|
1573.82 ng*hr/mL
Geometric Coefficient of Variation 63.46
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine
Day 5
|
857.64 ng*hr/mL
Geometric Coefficient of Variation 9.94
|
1210.92 ng*hr/mL
Geometric Coefficient of Variation 49.07
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine
Day 1
|
745.50 ng/mL
Geometric Coefficient of Variation 57.90
|
1056.66 ng/mL
Geometric Coefficient of Variation 93.01
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine
Day 5
|
632.56 ng/mL
Geometric Coefficient of Variation 45.86
|
668.11 ng/mL
Geometric Coefficient of Variation 91.64
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine
Day 1
|
0.25 hours
Interval 0.25 to 0.5
|
0.50 hours
Interval 0.25 to 1.5
|
—
|
—
|
—
|
—
|
—
|
|
Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine
Day 5
|
0.38 hours
Interval 0.25 to 0.5
|
0.64 hours
Interval 0.25 to 1.03
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine
Day 1
|
1.19 hours
Geometric Coefficient of Variation 102.56 • Interval 102.56 to
|
0.97 hours
Geometric Coefficient of Variation 43.88
|
—
|
—
|
—
|
—
|
—
|
|
Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine
Day 5
|
1.03 hours
Geometric Coefficient of Variation 76.95
|
1.15 hours
Geometric Coefficient of Variation 53.86
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf.
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine
Day 1
|
151.55 liters/hour
Geometric Coefficient of Variation 30.88
|
85.76 liters/hour
Geometric Coefficient of Variation 68.83
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine
Day 5
|
166.95 liters/hour
Geometric Coefficient of Variation 27.59
|
111.55 liters/hour
Geometric Coefficient of Variation 51.75
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dosePopulation: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
The apparent volume of distribution of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=6 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=6 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine
Day 1
|
259.44 liters
Geometric Coefficient of Variation 121.71
|
120.47 liters
Geometric Coefficient of Variation 120.45
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine
Day 5
|
248.57 liters
Geometric Coefficient of Variation 115.10
|
184.54 liters
Geometric Coefficient of Variation 104.34
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).Population: Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.
A serious adverse event is one that at any dose of the study drug or at any time during the period of observation: * Results in death; * Is life threatening; * Requires inpatient hospitalization or prolongation of existing hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly/birth defect; * Is medically important. The Investigator assessed each AE for potential causal relationship between the event and study drug. The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5).
Outcome measures
| Measure |
Azacitidine 25 mg/m^2
n=5 Participants
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 Participants
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 Participants
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
n=6 Participants
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
n=14 Participants
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
n=4 Participants
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
4 participants
|
3 participants
|
6 participants
|
5 participants
|
6 participants
|
14 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse event related to study drug
|
2 participants
|
3 participants
|
4 participants
|
4 participants
|
3 participants
|
8 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event
|
0 participants
|
0 participants
|
4 participants
|
1 participants
|
1 participants
|
8 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event related to study drug
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
Grade 3 or 4 adverse event
|
0 participants
|
0 participants
|
4 participants
|
1 participants
|
3 participants
|
10 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to study drug discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to study drug interruption
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to a dose reduction
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to other action taken
|
2 participants
|
1 participants
|
6 participants
|
4 participants
|
5 participants
|
10 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs)
Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
Adverse Events
Azacitidine 25 mg/m^2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Azacitidine 50 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Azacitidine 75 mg/m^2
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Azacitidine 100 mg/m^2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Severe RI: Azacitidine 75 mg/m^2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Extension Phase: Normal RF
Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths
Extension Phase: Severe RI
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azacitidine 25 mg/m^2
n=5 participants at risk
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 participants at risk
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 participants at risk
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 participants at risk
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
n=6 participants at risk
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
n=14 participants at risk
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
n=4 participants at risk
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Device dislocation
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Fatigue
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
50.0%
2/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
Other adverse events
| Measure |
Azacitidine 25 mg/m^2
n=5 participants at risk
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
|
Azacitidine 50 mg/m^2
n=5 participants at risk
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
|
Azacitidine 75 mg/m^2
n=6 participants at risk
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Azacitidine 100 mg/m^2
n=5 participants at risk
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
|
Severe RI: Azacitidine 75 mg/m^2
n=6 participants at risk
Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
|
Extension Phase: Normal RF
n=14 participants at risk
Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
Extension Phase: Severe RI
n=4 participants at risk
Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
50.0%
2/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
28.6%
4/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
40.0%
2/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
50.0%
2/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
50.0%
3/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Asthenia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Catheter site erythema
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Chills
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Fatigue
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
60.0%
3/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
21.4%
3/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Gait disturbance
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Hernia pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site discomfort
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site erythema
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site haematoma
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site induration
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
40.0%
2/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site pruritus
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site rash
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site reaction
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site swelling
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Injection site vesicles
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Infections and infestations
Otitis media
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Investigations
Cardiac murmur
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Investigations
Platelet count increased
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
33.3%
2/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal neoplasm
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
14.3%
2/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
25.0%
1/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
16.7%
1/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
20.0%
1/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/5 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/6 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
7.1%
1/14 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
0.00%
0/4 • Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
- Publication restrictions are in place
Restriction type: OTHER