Trial Outcomes & Findings for Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma (NCT NCT01146834)
NCT ID: NCT01146834
Last Updated: 2019-12-27
Results Overview
The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
47 participants
Primary outcome timeframe
36 months
Results posted on
2019-12-27
Participant Flow
Participant milestones
| Measure |
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)
|
Arm B: VELCADE & G-CSF
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)
|
Arm C: CYCLOPHOSPHAMIDE & G-CSF
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C)
|
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
4
|
23
|
0
|
0
|
|
Overall Study
COMPLETED
|
17
|
4
|
21
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
n=20 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm B: VELCADE & G-CSF
n=4 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm C: CYCLOPHOSPHAMIDE & G-CSF
n=23 Participants
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
—
|
—
|
30 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
—
|
—
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
—
|
—
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
—
|
—
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
—
|
—
|
44 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
—
|
—
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
—
|
—
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
—
|
5 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Arm A: 20 patients were enrolled but only 17 were evaluable. Arm C: 23 patients enrolled but only 21 were evaluable. Arm D and Arm E of the study did not accrue any subjects, therefore the number of participants analyzed for this outcome measure is 0 for both arms.
The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E.
Outcome measures
| Measure |
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
n=17 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm B: VELCADE & G-CSF
n=4 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm C: CYCLOPHOSPHAMIDE & G-CSF
n=21 Participants
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
|---|---|---|---|---|---|
|
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
|
11 Participants
|
0 Participants
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 20 days post-transplantPopulation: Data analyzed only for patients who went on to receive a stem cell transplant after mobilization. 25 subject did not receive a stem cell transplant after mobilization and therefore are not included in the analysis. However, no statistical test can be performed because the outcome proportion was 100% in each group.
Number of patients who achieved neutrophil recovery after Melphalan 200 based transplant in 20 days or fewer. Neutrophil recovery is defined as an absolute neutrophil count of greater than 0.5 k/uL for three consecutive days.
Outcome measures
| Measure |
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
n=7 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm B: VELCADE & G-CSF
n=4 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm C: CYCLOPHOSPHAMIDE & G-CSF
n=11 Participants
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
|---|---|---|---|---|---|
|
Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
|
7 Participants
|
4 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 20 days post-transplantPopulation: Data analyzed only for patients who went on to receive a stem cell transplant after mobilization. 25 subject did not receive a stem cell transplant after mobilization and therefore are not included in the analysis.
Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.
Outcome measures
| Measure |
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
n=7 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm B: VELCADE & G-CSF
n=4 Participants
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm C: CYCLOPHOSPHAMIDE & G-CSF
n=11 Participants
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
|---|---|---|---|---|---|
|
Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
|
4 Participants
|
1 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm B: VELCADE & G-CSF
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm C: CYCLOPHOSPHAMIDE & G-CSF
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Arm D: PLERIXAFOR & G-CSF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
n=20 participants at risk
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm B: VELCADE & G-CSF
n=4 participants at risk
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm C: CYCLOPHOSPHAMIDE & G-CSF
n=23 participants at risk
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
Other adverse events
| Measure |
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
n=20 participants at risk
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm B: VELCADE & G-CSF
n=4 participants at risk
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm C: CYCLOPHOSPHAMIDE & G-CSF
n=23 participants at risk
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
cyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
|
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
bortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11
G-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Plerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
50.0%
2/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
25.0%
1/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Investigations
White blood cell count decreased
|
20.0%
4/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
50.0%
2/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
34.8%
8/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
8/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
50.0%
2/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
21.7%
5/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Investigations
Platelet count decreased
|
35.0%
7/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
100.0%
4/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
47.8%
11/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
50.0%
2/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
30.4%
7/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Metabolism and nutrition disorders
hypoglycemia
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
General disorders
Fatigue
|
30.0%
6/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
26.1%
6/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
13.0%
3/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Hepatobiliary disorders
Gallbladder Pain
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
25.0%
1/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
50.0%
2/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
25.0%
1/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
20.0%
4/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
25.0%
1/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
17.4%
4/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Investigations
Serum creatinine increased
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
25.0%
1/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
5/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Investigations
INR increased
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
General disorders
Edema limbs
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Infections and infestations
Vulval infection
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
4/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Infections and infestations
Papulopustular rash
|
10.0%
2/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
8.7%
2/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
10.0%
2/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
General disorders
Chills
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Eye disorders
Other, Eye twitch
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Injury, poisoning and procedural complications
bruising; extremity
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
4.3%
1/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
Infections and infestations
Mucosal infection
|
5.0%
1/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
|
General disorders
Injection Site Reaction
|
0.00%
0/20 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
25.0%
1/4 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
0.00%
0/23 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
—
0/0 • Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent.
Arm D and Arm E did not enrolled any patients
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place