Trial Outcomes & Findings for Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies (NCT NCT02193958)
NCT ID: NCT02193958
Last Updated: 2025-03-19
Results Overview
Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
12 months
Results posted on
2025-03-19
Participant Flow
Participants were recruited based on physician referral at 2 academic medical centers between July 2014 and December 2018. The first participant was enrolled on August 21, 2014 and the last participant was enrolled on December 3, 2018. Study completion date was August 9, 2019.
For Phase 1, anticipated enrollment was 48 subjects; 38 subjects were enrolled and treated with FF-10501-01. For Phase 2, anticipated enrollment was 20 subjects; 17 were enrolled and treated with FF-10501-01.
Participant milestones
| Measure |
Phase 1 Cohort 1: 50mg/m2
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 2: 100mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 3: 200mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 4: 300mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 5: 400mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 6: 500mg/m2
FF-10501-01 tablets BID every 14 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 7: 400mg/m2 in MDS/CMML
FF-10501-01 tablets BID for 21 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 8: 400mg/m2
FF-10501-01 tablets BID for 28 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 2a Cohort 9: 400mg/m2
FF-10501-01 tablets BID for 21 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
4
|
7
|
5
|
5
|
7
|
17
|
|
Overall Study
Treated
|
3
|
3
|
4
|
4
|
7
|
5
|
5
|
7
|
17
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
4
|
7
|
5
|
3
|
7
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1 Cohort 1: 50mg/m2
n=3 Participants
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 2: 100mg/m2
n=3 Participants
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 3: 200mg/m2
n=4 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 4: 300mg/m2
n=4 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 5: 400mg/m2
n=7 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 6: 500mg/m2
n=5 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 7: 400mg/m2
n=5 Participants
FF-10501-01 tablets BID every 21 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 8: 400mg/m2
n=7 Participants
FF-10501-01 tablets BID for 28 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 2a Cohort 9: 400mg/m2
n=17 Participants
FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
16 Participants
n=114 Participants
|
47 Participants
|
|
Age, Continuous
|
73.67 years
STANDARD_DEVIATION 4.04 • n=99 Participants
|
69.00 years
STANDARD_DEVIATION 11.79 • n=107 Participants
|
66.25 years
STANDARD_DEVIATION 9.36 • n=206 Participants
|
76.00 years
STANDARD_DEVIATION 5.35 • n=7 Participants
|
79.00 years
STANDARD_DEVIATION 5.72 • n=31 Participants
|
71.00 years
STANDARD_DEVIATION 9.14 • n=30 Participants
|
77.40 years
STANDARD_DEVIATION 3.78 • n=3 Participants
|
73.29 years
STANDARD_DEVIATION 9.36 • n=6 Participants
|
73.00 years
STANDARD_DEVIATION 6.68 • n=114 Participants
|
73.44 years
STANDARD_DEVIATION 7.355
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
34 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
16 Participants
n=114 Participants
|
49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
4 participants
n=7 Participants
|
7 participants
n=31 Participants
|
5 participants
n=30 Participants
|
5 participants
n=3 Participants
|
7 participants
n=6 Participants
|
17 participants
n=114 Participants
|
55 participants
|
PRIMARY outcome
Timeframe: 12 monthsSafety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity
Outcome measures
| Measure |
Phase 1 Cohort 1: 50mg/m2
n=3 Participants
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 2: 100mg/m2
n=3 Participants
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 3: 200mg/m2
n=4 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 4: 300mg/m2
n=4 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 5: 400mg/m2
n=7 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 6: 500mg/m2
n=5 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 7: 400mg/m2
n=5 Participants
FF-10501-01 tablets BID every 21 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 8: 400mg/m2
n=7 Participants
FF-10501-01 tablets BID for 28 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 2a Cohort 9: 400mg/m2
n=17 Participants
FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Safety Assessed by Adverse Events
Any TEAEs
|
3 participants
|
3 participants
|
4 participants
|
4 participants
|
7 participants
|
5 participants
|
5 participants
|
7 participants
|
17 participants
|
|
Safety Assessed by Adverse Events
Any study drug related TEAEs
|
3 participants
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
14 participants
|
|
Safety Assessed by Adverse Events
Any serious TEAEs
|
2 participants
|
2 participants
|
4 participants
|
3 participants
|
7 participants
|
5 participants
|
4 participants
|
7 participants
|
11 participants
|
|
Safety Assessed by Adverse Events
Grade 3 or 4 TEAEs
|
2 participants
|
2 participants
|
4 participants
|
3 participants
|
6 participants
|
3 participants
|
4 participants
|
7 participants
|
15 participants
|
|
Safety Assessed by Adverse Events
Grade 3 or 4 study drug related TEAEs
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
6 participants
|
|
Safety Assessed by Adverse Events
Interruption of study drug due to TEAEs
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
3 participants
|
5 participants
|
7 participants
|
|
Safety Assessed by Adverse Events
Death due to TEAEs
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
1 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: OR responses were assessed at end of Cycles 1 thru 3. Each cycle was 28 days in length.The OR endpoint: proportion of subjects w/ OR as best response (CR, CRi or PR) assessed at the end of Cycles 1 and 3. AML: CR - free of all symptoms related to leukemia, absolute neutrophil count \> 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, normal bone marrow with \< 5% blasts no Auer rods; CRi - CR with residual thrombocytopenia (platelet count \< 100 x 10\^9/L) or residual neutropenia (absolute neutrophil count \< 1.0 x 10\^9/L); PR - A ≥ 50% decrease in bone marrow blasts to 5 to 25% abnormal. MDS or CMML: CR - free of all symptoms related to leukemia, absolute neutrophil count ≥ 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, bone marrow ≤ 5% myeloblasts, w/ normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood; PR - All CR criteria with ≥50% decrease in bone marrow blasts over pre-treatment (but still \> 5%); Marrow CR - In bone marrow, ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment.
Outcome measures
| Measure |
Phase 1 Cohort 1: 50mg/m2
n=3 Participants
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 2: 100mg/m2
n=3 Participants
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 3: 200mg/m2
n=4 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 4: 300mg/m2
n=4 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 5: 400mg/m2
n=7 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 6: 500mg/m2
n=5 Participants
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 7: 400mg/m2
n=5 Participants
FF-10501-01 tablets BID every 21 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 8: 400mg/m2
n=7 Participants
FF-10501-01 tablets BID for 28 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 2a Cohort 9: 400mg/m2
n=17 Participants
FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Determination of Objective Response (OR) Rates.
Complete bone marrow remission (mCR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Determination of Objective Response (OR) Rates.
Partial Response subjects
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
Phase 1 Cohort 1: 50mg/m2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1 Cohort 2: 100mg/m2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1 Cohort 3: 200mg/m2
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1 Cohort 4: 300mg/m2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1 Cohort 5: 400mg/m2
Serious events: 7 serious events
Other events: 7 other events
Deaths: 7 deaths
Phase 1 Cohort 6: 500mg/m2
Serious events: 5 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1 Cohort 7: 400mg/m2
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 1 Cohort 8: 400mg/m2
Serious events: 7 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase 2a Cohort 9: 400mg/m2
Serious events: 15 serious events
Other events: 17 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Phase 1 Cohort 1: 50mg/m2
n=3 participants at risk
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 2: 100mg/m2
n=3 participants at risk
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 3: 200mg/m2
n=4 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 4: 300mg/m2
n=4 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 5: 400mg/m2
n=7 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 6: 500mg/m2
n=5 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 7: 400mg/m2
n=5 participants at risk
FF-10501-01 tablets BID every 21 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 8: 400mg/m2
n=7 participants at risk
FF-10501-01 tablets BID for 28 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 2a Cohort 9: 400mg/m2
n=17 participants at risk
FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
pneumonia
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Number of events 4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Number of events 3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Number of events 5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
40.0%
2/5 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
85.7%
6/7 • Number of events 9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Number of events 3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
cellulitis
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
11.8%
2/17 • Number of events 3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
septic shock
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
hemorrhage intracranial
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Blood and lymphatic system disorders
histiocytosis hematophagic
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
pyrexia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Vascular disorders
hematoma
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
mucosal inflammation
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
enterocolitis infection
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
sepsis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Vascular disorders
hypertension
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
tumor lysis syndrome
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Cardiac disorders
pericardial effusion
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Cardiac disorders
pericarditis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
40.0%
2/5 • Number of events 3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
upper gastrointestinal hemorrhage
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
melena
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
tooth infection
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
enterobacter bacteremia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
ecthyma
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
periorbital cellulitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
stenotrophomonas infection
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
escherichia bacteremia/sepsis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Renal and urinary disorders
renal failure acute
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
acute febrile neutrophilic dermatosis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
enterococcla infection
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
clostridium difficile colitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
sinusitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
stomatitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
11.8%
2/17 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
5.9%
1/17 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
Other adverse events
| Measure |
Phase 1 Cohort 1: 50mg/m2
n=3 participants at risk
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 2: 100mg/m2
n=3 participants at risk
FF-10501-01 tablets BID for 14 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 3: 200mg/m2
n=4 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 4: 300mg/m2
n=4 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 5: 400mg/m2
n=7 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 6: 500mg/m2
n=5 participants at risk
FF-10501-01 tablets BID for 14 days of a 28-day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 7: 400mg/m2
n=5 participants at risk
FF-10501-01 tablets BID every 21 days of a 28 day cycle.
FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 1 Cohort 8: 400mg/m2
n=7 participants at risk
FF-10501-01 tablets BID for 28 days of a 28-day cycle
FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
Phase 2a Cohort 9: 400mg/m2
n=17 participants at risk
FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
40.0%
2/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
constipation
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
40.0%
2/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
diarrhea
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
71.4%
5/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
29.4%
5/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
nausea
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
75.0%
3/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
71.4%
5/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
41.2%
7/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
stomatitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
29.4%
5/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
fatigue
|
100.0%
3/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
edema peripheral
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
pyrexia
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
gait disturbance
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
General disorders
mucosal inflammation
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Infections and infestations
cellulitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
fall
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
40.0%
2/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Investigations
blood bilirubin increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Investigations
platelet count decreased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
decreased appetitie
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
hyperglycemia
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Nervous system disorders
dizziness
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
23.5%
4/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Psychiatric disorders
confusional state
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
40.0%
2/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
71.4%
5/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Psychiatric disorders
delirium
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
75.0%
3/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
75.0%
3/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
17.6%
3/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
50.0%
2/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
60.0%
3/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
35.3%
6/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
25.0%
1/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
|
Vascular disorders
hypotension
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/4 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
20.0%
1/5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
57.1%
4/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
0.00%
0/17 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions do not differ from clinicaltrials.gov
|
Additional Information
Vice President of Clinical Operations
FUJIFILM Pharmaceuticals U.S.A, Inc.
Phone: (617) 945-3763
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place