Trial Outcomes & Findings for Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma (NCT NCT04925193)
NCT ID: NCT04925193
Last Updated: 2026-04-07
Results Overview
To evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
End of Therapy, on average 10 months
Results posted on
2026-04-07
Participant Flow
Participant milestones
| Measure |
Arm 1
Selinexor 60 mg PO days 1, 8, 15 Pomalidomide 4 mg PO on days 1-21 Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22 28 day treatment cycles
|
Arm 2
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle
|
Arm 3
Selinexor 80 mg PO days 1, 8, 15 Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 28 day treatment cycle
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
9
|
|
Overall Study
COMPLETED
|
3
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1
n=3 Participants
Selinexor 60 mg PO days 1, 8, 15 Pomalidomide 4 mg PO on days 1-21 Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22 28 day treatment cycles
|
Arm 2
n=6 Participants
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle
|
Arm 3
n=9 Participants
Selinexor 80 mg PO days 1, 8, 15 Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 28 day treatment cycle
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
11 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: End of Therapy, on average 10 monthsTo evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
Outcome measures
| Measure |
Arm 1
n=3 Participants
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 Participants
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 Participants
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
Overall Response Rate
|
3 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 years following End of Treatment or date of progression (whichever comes first), assessed up to 2 yearsPopulation: The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.
To evaluate the minimal residual disease negative response rate achieved with physician's choice selinexor-based combination therapy assessed via NGS or multiparametric flow cytometry with sensitivity of 10-5.
Outcome measures
| Measure |
Arm 1
n=3 Participants
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 Participants
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 Participants
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
MRD Negative Response Rate
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 yearsPopulation: The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. This analysis was preplanned in the study protocol. Analysis of the secondary endpoint of progression free survival will be performed on the Intent-to-treat (ITT) population, which will include all subjects who have been enrolled for the study.
To evaluate the duration of progression free survival achieved with physician's choice selinexor-based combination therapy
Outcome measures
| Measure |
Arm 1
n=3 Participants
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 Participants
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 Participants
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
Progression Free Survival
|
7.6 Months
Interval 2.8 to 12.4
|
12.7 Months
Interval 4.5 to 20.9
|
17.2 Months
Interval 3.2 to 31.2
|
SECONDARY outcome
Timeframe: EOT + 2 years, or date of progression (whichever comes first)To evaluate the duration of overall survival achieved with physician's choice selinexor-based combination therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 yearsPopulation: The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. This analysis was preplanned in the study protocol. Analysis of the secondary endpoint of duration of response will be performed on the Intent-to-treat (ITT) population, which will include all subjects who have been enrolled for the study.
To evaluate the duration of response achieved with physician's choice selinexor-based combination therapy
Outcome measures
| Measure |
Arm 1
n=3 Participants
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 Participants
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 Participants
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
Duration of Response
|
3.08 Months
Interval 0.7 to 6.7
|
7.9 Months
Interval 3.2 to 10.5
|
11.9 Months
Interval 4.6 to 16.1
|
SECONDARY outcome
Timeframe: End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 yearsPopulation: The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.
To evaluate the time to next treatment achieved with physician's choice selinexor-based combination therapy
Outcome measures
| Measure |
Arm 1
n=3 Participants
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 Participants
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 Participants
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
Time to Next Treatment
|
9.6 Months
Interval 4.5 to 13.1
|
10.4 Months
Interval 6.7 to 16.8
|
10.8 Months
Interval 2.0 to 17.17
|
SECONDARY outcome
Timeframe: From first dose of study drug through 30 days after last dose of protocol required therapiesPopulation: Outcome measure data table indicates number of patients who experienced adverse events on each arm. Refer to adverse events table for detailed information.
Occurrence, nature, and severity of adverse events
Outcome measures
| Measure |
Arm 1
n=3 Participants
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 Participants
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 Participants
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
Safety and Tolerability of Selinexor in Combination With Partner Backbone Agents
|
3 Participants
|
6 Participants
|
9 Participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Arm 3
Serious events: 4 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm 1
n=3 participants at risk
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 participants at risk
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 participants at risk
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Arm 1
n=3 participants at risk
* Selinexor 60 mg PO days 1, 8, 15
* Pomalidomide 4 mg PO on days 1-21
* Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22
* 28 day treatment cycles
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Pomalidomide: Oral Table
Dexamethasone: Oral tablet or injection
|
Arm 2
n=6 participants at risk
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles \>6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Daratumumab: Injection Dexamethasone: Oral tablet or injection
|
Arm 3
n=9 participants at risk
* Selinexor 80 mg PO days 1, 8, 15
* Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
* Dexamethasone 40 mg IV or PO days 1, 8, 15, 22
* 28 day treatment cycle
Selinexor: Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
Carfilzomib: Injection
Dexamethasone: Oral tablet or injection
|
|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
General Disorders and Administration Site Conditions
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infections and Infestations
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
50.0%
3/6 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 5 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Psychiatric disorders
depression
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
50.0%
3/6 • Number of events 4 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Dry mouth
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 8 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 7 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
77.8%
7/9 • Number of events 8 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 4 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
66.7%
4/6 • Number of events 5 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 4 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
66.7%
4/6 • Number of events 8 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
55.6%
5/9 • Number of events 6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 15 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
66.7%
4/6 • Number of events 8 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 4 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Cardiac disorders
Pericardial tamponade
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Ear and labyrinth disorders
Periorbital edema
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 12 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
66.7%
4/6 • Number of events 8 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
55.6%
5/9 • Number of events 15 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Infections and infestations
Tooth infection
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 4 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Urine output decreased
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
3/9 • Number of events 3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Ear and labyrinth disorders
Watering eyes
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Weight gain
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
22.2%
2/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 2 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/6 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Number of events 8 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
33.3%
2/6 • Number of events 4 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
11.1%
1/9 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
|
Investigations
Investigations - Other, Specify
|
0.00%
0/3 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
16.7%
1/6 • Number of events 1 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
0.00%
0/9 • Adverse Events were assessed from C1D1 through 30 days post last dose (approximately 10 months). Deaths were assessed up to 2 years following end of treatment.
adverse event definitions do not differ from the clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place