Trial Outcomes & Findings for Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NCT NCT00295932)
NCT ID: NCT00295932
Last Updated: 2018-11-20
Results Overview
Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
79 participants
Primary outcome timeframe
2 years
Results posted on
2018-11-20
Participant Flow
Participant milestones
| Measure |
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
|
Weekly Bortezomib Dosing Schedule
Phase II Randomized Weekly bortezomib dosing schedule
|
Twice-weekly Bortezomib Dosing Schedule
Phase II Randomized Twice-weekly bortezomib dosing schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
3
|
4
|
2
|
18
|
3
|
4
|
10
|
12
|
13
|
|
Overall Study
COMPLETED
|
4
|
6
|
3
|
4
|
2
|
18
|
3
|
4
|
10
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
|
Weekly Bortezomib Dosing Schedule
Phase II Randomized Weekly bortezomib dosing schedule
|
Twice-weekly Bortezomib Dosing Schedule
Phase II Randomized Twice-weekly bortezomib dosing schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
n=4 Participants
Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
n=6 Participants
Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=3 Participants
Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=4 Participants
Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=2 Participants
Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=18 Participants
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
n=3 Participants
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
n=4 Participants
Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
n=10 Participants
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
|
Weekly Bortezomib Dosing Schedule
n=12 Participants
Phase II Randomized Weekly bortezomib dosing schedule
|
Twice-weekly Bortezomib Dosing Schedule
n=13 Participants
Phase II Randomized Twice-weekly bortezomib dosing schedule
|
Total
n=79 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=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
42 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
40 Participants
n=42 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=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 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=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
68 Participants
n=42 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=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This outcome is only applicable for Phase I portion of the study. The purpose of the Phase I portion of the study is to determine the Maximum Tolerated Dose and for this reason the results are not separated by dose level.
Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants
Outcome measures
| Measure |
Arm I
n=54 Participants
Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2, 5, 9, and 12. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
bortezomib: Given IV
cyclophosphamide: Given IV
prednisone: Given orally
|
Arm II
Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
bortezomib: Given IV
cyclophosphamide: Given IV
prednisone: Given orally
|
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
|
Weekly Bortezomib Dosing Schedule
Phase II Randomized Weekly bortezomib dosing schedule
|
Twice-weekly Bortezomib Dosing Schedule
Phase II Randomized Twice-weekly bortezomib dosing schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose
Weekly Bortezomib
|
1.8 mg/m^2 of Bortezomib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose
Twice-Weekly Bortezomib
|
1.5 mg/m^2 of Bortezomib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsToxicity assessed using NCI-CTC v. 3.0
Outcome measures
| Measure |
Arm I
n=4 Participants
Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2, 5, 9, and 12. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
bortezomib: Given IV
cyclophosphamide: Given IV
prednisone: Given orally
|
Arm II
n=6 Participants
Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
rituximab: Given IV
bortezomib: Given IV
cyclophosphamide: Given IV
prednisone: Given orally
|
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=3 Participants
Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=4 Participants
Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=2 Participants
Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=18 Participants
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
n=3 Participants
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
n=4 Participants
Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
n=10 Participants
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
|
Weekly Bortezomib Dosing Schedule
n=12 Participants
Phase II Randomized Weekly bortezomib dosing schedule
|
Twice-weekly Bortezomib Dosing Schedule
n=13 Participants
Phase II Randomized Twice-weekly bortezomib dosing schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma
|
4 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
18 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
12 Participants
|
13 Participants
|
Adverse Events
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 3 deaths
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
Serious events: 5 serious events
Other events: 18 other events
Deaths: 13 deaths
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
Serious events: 1 serious events
Other events: 10 other events
Deaths: 7 deaths
Weekly Bortezomib Dosing Schedule
Serious events: 4 serious events
Other events: 12 other events
Deaths: 4 deaths
Twice-weekly Bortezomib Dosing Schedule
Serious events: 8 serious events
Other events: 13 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
n=4 participants at risk
Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
n=6 participants at risk
Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=3 participants at risk
Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=4 participants at risk
Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=2 participants at risk
Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=18 participants at risk
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
n=3 participants at risk
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
n=4 participants at risk
Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
n=10 participants at risk
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
|
Weekly Bortezomib Dosing Schedule
n=12 participants at risk
Phase II Randomized Weekly bortezomib dosing schedule
|
Twice-weekly Bortezomib Dosing Schedule
n=13 participants at risk
Phase II Randomized Twice-weekly bortezomib dosing schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • 1 year
|
50.0%
3/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
16.7%
2/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
25.0%
3/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Fever
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Hemorrhage/Bleeding, other
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Injury, poisoning and procedural complications
Hemorrhage/Bleeding assoc w/surg, intra/ post-op
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Infection, other
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Pain
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Investigations
Platelets
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
15.4%
2/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
Other adverse events
| Measure |
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
n=4 participants at risk
Phase I Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
n=6 participants at risk
Phase I Weekly 1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=3 participants at risk
Phase I Weekly 1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
n=4 participants at risk
Phase I Weekly 1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=2 participants at risk
Phase I Twice Weekly 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid
n=18 participants at risk
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide
|
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
n=3 participants at risk
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami
n=4 participants at risk
Phase I Twice Weekly 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide
|
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham
n=10 participants at risk
Phase I Twice Weekly 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide; Pegylated G-CSF
|
Weekly Bortezomib Dosing Schedule
n=12 participants at risk
Phase II Randomized Weekly bortezomib dosing schedule
|
Twice-weekly Bortezomib Dosing Schedule
n=13 participants at risk
Phase II Randomized Twice-weekly bortezomib dosing schedule
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • 1 year
|
50.0%
3/6 • 1 year
|
0.00%
0/3 • 1 year
|
50.0%
2/4 • 1 year
|
50.0%
1/2 • 1 year
|
66.7%
12/18 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 1 year
|
33.3%
2/6 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
3/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
25.0%
3/12 • 1 year
|
15.4%
2/13 • 1 year
|
|
General disorders
Fatigue
|
50.0%
2/4 • 1 year
|
50.0%
3/6 • 1 year
|
66.7%
2/3 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/2 • 1 year
|
55.6%
10/18 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
40.0%
4/10 • 1 year
|
16.7%
2/12 • 1 year
|
15.4%
2/13 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • 1 year
|
16.7%
1/6 • 1 year
|
66.7%
2/3 • 1 year
|
100.0%
4/4 • 1 year
|
0.00%
0/2 • 1 year
|
33.3%
6/18 • 1 year
|
33.3%
1/3 • 1 year
|
75.0%
3/4 • 1 year
|
30.0%
3/10 • 1 year
|
41.7%
5/12 • 1 year
|
38.5%
5/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • 1 year
|
33.3%
2/6 • 1 year
|
100.0%
3/3 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
3/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
20.0%
2/10 • 1 year
|
25.0%
3/12 • 1 year
|
46.2%
6/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • 1 year
|
33.3%
2/6 • 1 year
|
66.7%
2/3 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/2 • 1 year
|
27.8%
5/18 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
30.0%
3/10 • 1 year
|
50.0%
6/12 • 1 year
|
15.4%
2/13 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
75.0%
3/4 • 1 year
|
66.7%
4/6 • 1 year
|
66.7%
2/3 • 1 year
|
75.0%
3/4 • 1 year
|
100.0%
2/2 • 1 year
|
83.3%
15/18 • 1 year
|
100.0%
3/3 • 1 year
|
100.0%
4/4 • 1 year
|
90.0%
9/10 • 1 year
|
83.3%
10/12 • 1 year
|
76.9%
10/13 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
16.7%
3/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
30.0%
3/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
1/3 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/2 • 1 year
|
55.6%
10/18 • 1 year
|
33.3%
1/3 • 1 year
|
50.0%
2/4 • 1 year
|
30.0%
3/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 1 year
|
50.0%
3/6 • 1 year
|
0.00%
0/3 • 1 year
|
100.0%
4/4 • 1 year
|
100.0%
2/2 • 1 year
|
44.4%
8/18 • 1 year
|
66.7%
2/3 • 1 year
|
50.0%
2/4 • 1 year
|
40.0%
4/10 • 1 year
|
41.7%
5/12 • 1 year
|
76.9%
10/13 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • 1 year
|
83.3%
5/6 • 1 year
|
66.7%
2/3 • 1 year
|
100.0%
4/4 • 1 year
|
0.00%
0/2 • 1 year
|
44.4%
8/18 • 1 year
|
66.7%
2/3 • 1 year
|
50.0%
2/4 • 1 year
|
50.0%
5/10 • 1 year
|
66.7%
8/12 • 1 year
|
61.5%
8/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
22.2%
4/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
16.7%
2/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • 1 year
|
83.3%
5/6 • 1 year
|
66.7%
2/3 • 1 year
|
100.0%
4/4 • 1 year
|
100.0%
2/2 • 1 year
|
50.0%
9/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
5/10 • 1 year
|
75.0%
9/12 • 1 year
|
69.2%
9/13 • 1 year
|
|
Investigations
White blood cell decreased
|
50.0%
2/4 • 1 year
|
66.7%
4/6 • 1 year
|
66.7%
2/3 • 1 year
|
100.0%
4/4 • 1 year
|
100.0%
2/2 • 1 year
|
50.0%
9/18 • 1 year
|
33.3%
1/3 • 1 year
|
50.0%
2/4 • 1 year
|
50.0%
5/10 • 1 year
|
83.3%
10/12 • 1 year
|
69.2%
9/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
1/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
16.7%
2/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
16.7%
2/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Pain
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
50.0%
2/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
15.4%
2/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
16.7%
2/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Blood Bilirubin Increased
|
25.0%
1/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Fever
|
25.0%
1/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
1/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
INR Increased
|
25.0%
1/4 • 1 year
|
0.00%
0/6 • 1 year
|
66.7%
2/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
20.0%
2/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 1 year
|
33.3%
2/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
33.3%
1/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 1 year
|
16.7%
1/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Weight gain
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
50.0%
1/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Bladder infection
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
8.3%
1/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
11.1%
2/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
5.6%
1/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
33.3%
1/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
25.0%
1/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Eye infection
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
10.0%
1/10 • 1 year
|
0.00%
0/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
16.7%
2/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder Other, spec
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/4 • 1 year
|
0.00%
0/6 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/2 • 1 year
|
0.00%
0/18 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/4 • 1 year
|
0.00%
0/10 • 1 year
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
Additional Information
Dr. Carol Portlock
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8109
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place