Trial Outcomes & Findings for Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma (NCT NCT02257242)
NCT ID: NCT02257242
Last Updated: 2023-02-09
Results Overview
Determined as the median of the marginal posterior distribution using data from all available patients
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Up to 6 cycles of treatment (approximately 6 months)
Results posted on
2023-02-09
Participant Flow
Participant milestones
| Measure |
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
1
|
2
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
1 subject removed from study before any treatment due to temporary unavailability of study drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
n=2 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
n=2 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
7 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
4 Participants
|
|
Age, Continuous
|
70 years
n=99 Participants
|
40 years
n=107 Participants
|
75 years
n=206 Participants
|
69 years
n=7 Participants
|
58 years
n=31 Participants
|
61 years
n=30 Participants
|
54 years
n=3 Participants
|
57 years
n=6 Participants
|
39 years
n=114 Participants
|
60 years
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
1 participants
n=31 Participants
|
1 participants
n=30 Participants
|
1 participants
n=3 Participants
|
1 participants
n=6 Participants
|
1 participants
n=114 Participants
|
11 participants
|
PRIMARY outcome
Timeframe: Up to 6 cycles of treatment (approximately 6 months)Determined as the median of the marginal posterior distribution using data from all available patients
Outcome measures
| Measure |
Dose-escalation Cohort
n=10 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose
|
2.24 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 cycles of treatment (approximately 6 months)Outcome measures
| Measure |
Dose-escalation Cohort
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
n=2 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Completed Six Cycles of Study Treatment
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 cycles of treatment (approximately 6 months)Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Dose-escalation Cohort
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
n=2 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Response Rate
Complete Response
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Response Rate
Partial Response
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate
Stable Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 cycles of treatment (approximately 6 months)The number of patients achieving complete response during treatment on study
Outcome measures
| Measure |
Dose-escalation Cohort
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
n=2 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
n=1 Participants
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Complete Response Rate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 2.1 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
n=2 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.1 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
General disorders
Fever
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
Other adverse events
| Measure |
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2
n=2 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.1 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2
n=1 participants at risk
Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
Alkaline phosphatase increased
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
General disorders
Chills
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
General disorders
Fever
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
2/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
2/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
2/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
General disorders
Neck edema
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Infections and infestations
Skin infection
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Renal and urinary disorders
Urinary frequency
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
Weight loss
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
50.0%
1/2 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
100.0%
1/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
0.00%
0/1 • Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place