Trial Outcomes & Findings for Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function (NCT NCT00721734)
NCT ID: NCT00721734
Last Updated: 2017-05-02
Results Overview
Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.
Results posted on
2017-05-02
Participant Flow
This study enrolled patients with multiple myeloma (MM) who had relapsed or progressive disease (PD) after at least 1 (original protocol) or 2 (following protocol Amendment 1) prior therapeutic treatments or regimens. Five groups of MM patients, representing different levels of renal function, were evaluated.
Participant milestones
| Measure |
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
10
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
0
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
8
|
6
|
6
|
Reasons for withdrawal
| Measure |
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
10
|
4
|
5
|
2
|
|
Overall Study
Adverse Event
|
3
|
1
|
4
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function
Baseline characteristics by cohort
| Measure |
Carfilzomib - Normal RF
n=12 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=12 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=10 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=8 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
26 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 5.70 • n=99 Participants
|
63.5 years
STANDARD_DEVIATION 7.85 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 9.65 • n=206 Participants
|
73.0 years
STANDARD_DEVIATION 8.23 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 7.91 • n=31 Participants
|
64.6 years
STANDARD_DEVIATION 9.01 • n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
1 participants
n=7 Participants
|
2 participants
n=31 Participants
|
11 participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
3 participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
6 participants
n=206 Participants
|
7 participants
n=7 Participants
|
5 participants
n=31 Participants
|
36 participants
n=30 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active)
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
0 participants
n=31 Participants
|
8 participants
n=30 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restrictive but ambulatory)
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
1 participants
n=7 Participants
|
5 participants
n=31 Participants
|
32 participants
n=30 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 (Ambulatory but unable to work)
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
5 participants
n=7 Participants
|
3 participants
n=31 Participants
|
10 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: The pharmacokinetic (PK) evaluable population includes participants with stable baseline renal function (Arms 1-4) who completed all protocol-specified treatment and PK blood sample collection through Cycle 1, Day 16. In Group 5, only samples collected before dialysis were included. CL could not be estimated for 11 patients in the PK population.
Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=6 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=6 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=3 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=4 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=5 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Clearance (CL) of Carfilzomib on Day 1 of Cycle 1
|
151 liters/hour
Standard Deviation 79.3
|
113 liters/hour
Standard Deviation 40.7
|
288 liters/hour
Standard Deviation 264
|
170 liters/hour
Standard Deviation 58.4
|
170 liters/hour
Standard Deviation 60.2
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: The pharmacokinetic (PK) evaluable population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=5 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=5 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=3 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=1 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=5 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Clearance (CL) of Carfilzomib on Day 15 of Cycle 1
|
660 liters/hour
Standard Deviation 1134
|
115 liters/hour
Standard Deviation 34.7
|
119 liters/hour
Standard Deviation 16.5
|
110 liters/hour
Standard Deviation NA
Can not be calculated for a sample of 1
|
114 liters/hour
Standard Deviation 61.2
|
SECONDARY outcome
Timeframe: Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: The pharmacokinetic (PK) evaluable population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=1 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=1 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Clearance (CL) of Carfilzomib on Day 15 of Cycle 2
|
—
|
—
|
679 liters/hour
Standard Deviation NA
Cannot be calculated for a sample of 1
|
46.6 liters/hour
Standard Deviation NA
Cannot be calculated for a sample of 1
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK population
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=8 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=9 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=5 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=5 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1
|
2077 ng/mL
Geometric Coefficient of Variation 91.4
|
1623 ng/mL
Geometric Coefficient of Variation 161
|
1840 ng/mL
Geometric Coefficient of Variation 92.4
|
1231 ng/mL
Geometric Coefficient of Variation 139
|
1539 ng/mL
Geometric Coefficient of Variation 92.7
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=7 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=8 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=5 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=4 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=6 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1
|
1768 ng/mL
Geometric Coefficient of Variation 179
|
2406 ng/mL
Geometric Coefficient of Variation 52.3
|
2627 ng/mL
Geometric Coefficient of Variation 31.8
|
1914 ng/mL
Geometric Coefficient of Variation 99.8
|
3236 ng/mL
Geometric Coefficient of Variation 34.4
|
SECONDARY outcome
Timeframe: Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=1 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=2 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2
|
—
|
—
|
244 ng/mL
Geometric Coefficient of Variation NA
Cannot be calculated for a sample of 1
|
3064 ng/mL
Geometric Coefficient of Variation 3.9
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK evaluable population; AUCinf could not be estimated for 11 participants in the PK population who did not have adequate PK data.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=6 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=6 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=3 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=4 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=5 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1
|
233 hr*ng/mL
Geometric Coefficient of Variation 51.6
|
241 hr*ng/mL
Geometric Coefficient of Variation 32.4
|
145 hr*ng/mL
Geometric Coefficient of Variation 111
|
172 hr*ng/mL
Geometric Coefficient of Variation 35.6
|
193 hr*ng/mL
Geometric Coefficient of Variation 55.2
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK evaluable population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=5 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=5 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=3 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=1 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=5 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1
|
127 hr*ng/mL
Geometric Coefficient of Variation 240
|
236 hr*ng/mL
Geometric Coefficient of Variation 44.3
|
257 hr*ng/mL
Geometric Coefficient of Variation 10.9
|
218 hr*ng/mL
Geometric Coefficient of Variation NA
Cannot be calculated for a sample of 1
|
272 hr*ng/mL
Geometric Coefficient of Variation 46.4
|
SECONDARY outcome
Timeframe: Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK evaluable population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=1 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=1 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2
|
—
|
—
|
48.6 hr*ng/mL
Geometric Coefficient of Variation NA
Cannot be calculated for a sample of 1
|
579 hr*ng/mL
Geometric Coefficient of Variation NA
Cannot be calculated for a sample of 1
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK evaluable population
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=8 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=9 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=5 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=5 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1
|
187 hr*ng/mL
Geometric Coefficient of Variation 75.3
|
194 hr*ng/mL
Geometric Coefficient of Variation 67.6
|
199 hr*ng/mL
Geometric Coefficient of Variation 91.3
|
135 hr*ng/mL
Geometric Coefficient of Variation 65.5
|
195 hr*ng/mL
Geometric Coefficient of Variation 65.3
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK evaluable population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=7 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=8 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=5 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=4 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=6 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1
|
159 hr*ng/mL
Geometric Coefficient of Variation 186
|
289 hr*ng/mL
Geometric Coefficient of Variation 58.5
|
371 hr*ng/mL
Geometric Coefficient of Variation 55.2
|
343 hr*ng/mL
Geometric Coefficient of Variation 53.1
|
264 hr*ng/mL
Geometric Coefficient of Variation 41.7
|
SECONDARY outcome
Timeframe: Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.Population: PK evaluable population with available data
Outcome measures
| Measure |
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=1 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=2 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2
|
—
|
—
|
47.3 hr*ng/mL
Geometric Coefficient of Variation NA
Cannot be calculated for a sample of 1
|
345 hr*ng/mL
Geometric Coefficient of Variation 83.6
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1, 0-5 and 5-24 hours post-dosePopulation: Participants in Groups 1-4 with available data
The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=8 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=8 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=7 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=5 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1
|
0.490 percentage of carfilzomib dose
Standard Deviation 0.316
|
0.429 percentage of carfilzomib dose
Standard Deviation 0.271
|
0.160 percentage of carfilzomib dose
Standard Deviation 0.101
|
0.226 percentage of carfilzomib dose
Standard Deviation 0.0921
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15, 0-5 and 5-24 hours post-dosePopulation: Participants in Groups 1-4 with available data
The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=7 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=6 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=5 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=4 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1
|
0.446 percentage of carfilzomib dose
Standard Deviation 0.357
|
0.428 percentage of carfilzomib dose
Standard Deviation 0.262
|
0.202 percentage of carfilzomib dose
Standard Deviation 0.116
|
0.168 percentage of carfilzomib dose
Standard Deviation 0.0670
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1, 0-5 and 5-24 hours post-dosePopulation: Participants in Groups 1-4 with available data
The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=8 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=9 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=7 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=5 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1
M14
|
33.1 percentage of carfilzomib dose
Standard Deviation 13.1
|
25.0 percentage of carfilzomib dose
Standard Deviation 4.81
|
21.7 percentage of carfilzomib dose
Standard Deviation 7.59
|
19.2 percentage of carfilzomib dose
Standard Deviation 4.36
|
—
|
|
Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1
M15
|
1.93 percentage of carfilzomib dose
Standard Deviation 1.12
|
1.42 percentage of carfilzomib dose
Standard Deviation 0.314
|
0.776 percentage of carfilzomib dose
Standard Deviation 0.387
|
0.578 percentage of carfilzomib dose
Standard Deviation 0.230
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15, 0-5 and 5-24 hours post-dosePopulation: Participants in Groups 1-4 with available data
The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=7 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=6 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=5 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=4 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1
M14
|
30.6 percentage of carfilzomib dose
Standard Deviation 11.6
|
27.0 percentage of carfilzomib dose
Standard Deviation 8.47
|
22.0 percentage of carfilzomib dose
Standard Deviation 6.89
|
17.0 percentage of carfilzomib dose
Standard Deviation 4.67
|
—
|
|
Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1
M15
|
1.91 percentage of carfilzomib dose
Standard Deviation 1.03
|
1.55 percentage of carfilzomib dose
Standard Deviation 0.602
|
0.856 percentage of carfilzomib dose
Standard Deviation 0.377
|
0.475 percentage of carfilzomib dose
Standard Deviation 0.249
|
—
|
SECONDARY outcome
Timeframe: End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15Population: Participants with available data
The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15).
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=11 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=8 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=9 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=9 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=7 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Plasma Protein Binding (PPB) of Carfilzomib
End of Injection
|
97.8 percentage of carfilzomib bound
Standard Deviation 0.6
|
97.6 percentage of carfilzomib bound
Standard Deviation 1.5
|
98.4 percentage of carfilzomib bound
Standard Deviation 0.4
|
98.2 percentage of carfilzomib bound
Standard Deviation 0.5
|
97.6 percentage of carfilzomib bound
Standard Deviation 0.7
|
|
Plasma Protein Binding (PPB) of Carfilzomib
5 minutes after injection
|
98.1 percentage of carfilzomib bound
Standard Deviation 0.5
|
97.6 percentage of carfilzomib bound
Standard Deviation 1.6
|
98.2 percentage of carfilzomib bound
Standard Deviation 1.5
|
98.1 percentage of carfilzomib bound
Standard Deviation 0.8
|
98.2 percentage of carfilzomib bound
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.Population: The response evaluable population included all participants with measurable disease and a baseline and at least 1 post-baseline disease assessment or who discontinued study treatment due to a related adverse event prior to obtaining an on-study disease assessment.
ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma. sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and \< 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of \< 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=11 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=11 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=9 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=8 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
18.2 percentage of participants
Interval 2.3 to 51.8
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.Population: The response evaluable population
Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=11 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=11 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=9 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=8 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: Participants were followed for disease progression for up to 2 years.Population: Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.
Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death. Progressive disease was defined as any of the following: * An increase of more than 25% from nadir in any one of the following: * M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL); * Urine (the absolute increase had to be ≥ 200 mg/24 hours); * The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be \> 10 mg/dL); * ≥ 10% bone marrow infiltration by plasma cells; * Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas. Median duration of response was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=2 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=3 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=2 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=2 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=3 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Duration of Response
|
NA months
Interval 2.0 to
Could not be estimated due to the low number of events
|
NA months
Interval 4.2 to
Could not be estimated due to the low number of events
|
14.8 months
Interval 2.3 to 27.4
|
NA months
Interval 7.9 to
Could not be estimated due to the low number of events
|
7.9 months
Interval 6.5 to 8.5
|
SECONDARY outcome
Timeframe: Participants were followed for disease progression for up to 2 years.Population: Response Evaluable Population
Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Carfilzomib - Normal RF
n=11 Participants
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=11 Participants
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=9 Participants
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=8 Participants
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 Participants
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
4.4 months
Interval 2.8 to 9.2
|
5.6 months
Interval 0.5 to 7.9
|
2.8 months
Interval 1.0 to 29.2
|
9.6 months
Interval 1.0 to 11.8
|
6.5 months
Interval 2.8 to 11.3
|
Adverse Events
Carfilzomib - Normal RF
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Carfilzomib - Mild RI
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Carfilzomib - Moderate RI
Serious events: 10 serious events
Other events: 10 other events
Deaths: 0 deaths
Carfilzomib - Severe RI
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Carfilzomib - Dialysis
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carfilzomib - Normal RF
n=12 participants at risk
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=12 participants at risk
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=10 participants at risk
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=8 participants at risk
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 participants at risk
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Immune system disorders
Amyloidosis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Central line infection
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Paronychia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Carfilzomib - Normal RF
n=12 participants at risk
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Mild RI
n=12 participants at risk
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Moderate RI
n=10 participants at risk
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Severe RI
n=8 participants at risk
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
Carfilzomib - Dialysis
n=8 participants at risk
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.
If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
6/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
58.3%
7/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
70.0%
7/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
62.5%
5/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
62.5%
5/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
4/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
4/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
4/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
6/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
5/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
62.5%
5/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Dilatation atrial
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Diplopia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye pain
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Keratitis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colonic haemorrhage
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colonic polyp
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
6/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
5/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.7%
5/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
6/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
5/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
6/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
4/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
60.0%
6/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Face oedema
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Facial pain
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
75.0%
9/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
75.0%
9/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
60.0%
6/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Generalised oedema
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Hypothermia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Infusion related reaction
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Infusion site pain
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Local swelling
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mass
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
33.3%
4/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pitting oedema
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Tenderness
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Seasonal allergy
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes simplex
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Paronychia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post procedural vomiting
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Abdominal bruit
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood calcium increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
5/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood glucose increased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood phosphorus decreased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood potassium decreased
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood potassium increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood pressure increased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.0%
3/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Cardiac murmur
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Ejection fraction decreased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Haemoglobin decreased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
International normalised ratio increased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Lymphocyte count decreased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Occult blood positive
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Troponin increased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Urine output decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
41.7%
5/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
4/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Overweight
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
41.7%
5/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Nodule on extremity
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
41.7%
5/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Areflexia
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Balance disorder
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Diplegia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathic pain
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.3%
4/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
6/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
3/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.0%
4/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
37.5%
3/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exacerbated
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
2/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
1/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.0%
2/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
25.0%
2/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
50.0%
4/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Pallor
|
8.3%
1/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Superior vena caval occlusion
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/12 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/10 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
1/8 • From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 121 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen, Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER