Trial Outcomes & Findings for Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas (NCT NCT02661542)
NCT ID: NCT02661542
Last Updated: 2026-04-23
Results Overview
Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Results posted on
2026-04-23
Participant Flow
Participants were recruited based on physician referral at 2 academic medical centers between January 2016 and November 2020. The first participant was dosed on January 14, 2016 and the last participant was dosed on October 3, 2020. Study completion date was November 5, 2020.
For Phase 1, anticipated enrollment was 40 subjects; 40 subjects were enrolled and treated with FF-10501-01. For Phase 2, anticipated enrollment was 66 subjects; 66 were enrolled and treated with FF-10501-01.
Participant milestones
| Measure |
Phase 1, Cohort 1
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
|
Phase 1 Cohort 2
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
|
Phase 1, Cohort 3
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
|
Phase 1, Cohort 4
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
|
Phase 1, Cohort 5
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
|
Phase 1, Cohort 6
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
|
Phase 1, Cohort 7
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
|
Phase 1, Cohort 8
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
|
Phase 1, Cohort 9
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
|
Phase 2a, Cohort 10, Advanced Solid Tumors
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 11, Cholangiocarcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
7
|
3
|
9
|
6
|
3
|
19
|
36
|
10
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
7
|
3
|
9
|
6
|
3
|
19
|
36
|
10
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas
Baseline characteristics by cohort
| Measure |
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Total
n=106 Participants
Total of all reporting groups
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43 years
n=20 Participants
|
62 years
n=12 Participants
|
66 years
n=5 Participants
|
59 years
n=42 Participants
|
64 years
n=12 Participants
|
59 years
n=26 Participants
|
62 years
n=6 Participants
|
61 years
n=7 Participants
|
59 years
n=60 Participants
|
65 years
n=56 Participants
|
67 years
n=116 Participants
|
63 years
n=7 Participants
|
67 years
n=3 Participants
|
65 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
2 Participants
n=12 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=42 Participants
|
7 Participants
n=12 Participants
|
1 Participants
n=26 Participants
|
60 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
1 Participants
n=12 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=42 Participants
|
3 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
46 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
11 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
3 Participants
n=12 Participants
|
17 Participants
n=5 Participants
|
30 Participants
n=42 Participants
|
9 Participants
n=12 Participants
|
1 Participants
n=26 Participants
|
93 Participants
n=6 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
2 Participants
n=12 Participants
|
16 Participants
n=5 Participants
|
27 Participants
n=42 Participants
|
10 Participants
n=12 Participants
|
1 Participants
n=26 Participants
|
90 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.Population: Safety Analysis Population
Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Any dose limiting toxicity (DLT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Study drug-related Treatment Emergent Adverse Events (TEAEs)
|
36 participants
|
10 participants
|
0 participants
|
3 participants
|
3 participants
|
3 participants
|
2 participants
|
7 participants
|
3 participants
|
8 participants
|
5 participants
|
3 participants
|
14 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Serious Treatment Emergent Adverse Events (TEAEs)
|
20 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
5 participants
|
0 participants
|
5 participants
|
5 participants
|
0 participants
|
14 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)
|
20 participants
|
5 participants
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
4 participants
|
2 participants
|
5 participants
|
5 participants
|
1 participants
|
17 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Discontinuations due to Treatment Emergent Adverse Events (TEAEs)
|
5 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Interruptions due to Treatment Emergent Adverse Events (TEAEs)
|
15 participants
|
5 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
2 participants
|
3 participants
|
5 participants
|
1 participants
|
5 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Death due to Treatment Emergent Adverse Events (TEAEs)
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Grade 3 or 4 drug-related Treatment Emergent Adverse Events (TEAEs)
|
6 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
2 participants
|
1 participants
|
6 participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Any Treatment Emergent Adverse Events (TEAEs)
|
36 participants
|
10 participants
|
0 participants
|
3 participants
|
3 participants
|
3 participants
|
3 participants
|
7 participants
|
3 participants
|
9 participants
|
6 participants
|
3 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle), up to 38 monthsPopulation: Full Analysis Set Population
Number of subjects who had overall responses of Partial Response, Stable Disease, Progressive Disease or Not Evaluable
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Overall Response Rates (ORR)
Partial Response
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Overall Response Rates (ORR)
Stable Disease
|
21 participants
|
3 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
4 participants
|
0 participants
|
8 participants
|
|
Number of Subjects With Overall Response Rates (ORR)
Progressive Disease
|
10 participants
|
6 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
3 participants
|
0 participants
|
3 participants
|
8 participants
|
|
Number of Subjects With Overall Response Rates (ORR)
Not Evaluable
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsNumber of subjects with objective response events, number of subjects with progressive disease or death events atter objective response and number of subjects censored after objective response
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Objective Response (OR) Events
Number of Subjects with Objective Response events
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Objective Response (OR) Events
Number of Subjects with Progressive Disease or death after Objective Response
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Objective Response (OR) Events
Number of Subjects Censored after Objective Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsMedian duration of objective response in days for each cohort".
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Number of Days of Objective Response (OR)
|
130 days
1 out of 36 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
68 days
1 out of 10 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
22 days
0 out of 1 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
NA days
0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
NA days
0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
30 days
1 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
NA days
0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
206 days
1 out of 7 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
115 days
1 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
NA days
0 out of 9 patients had an objective response, therefore the median and 95% confidence interval could not be calculated event
|
204 days
1 out of 6 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
NA days
0 out of 3 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
NA days
0 out of 19 patients had an objective response event, therefore the median and 95% confidence interval could not be calculated
|
SECONDARY outcome
Timeframe: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsPopulation: Full Analysis Set Population
Number of subjects with stable disease, number of subjects with progressive disease or death after stable disease and number of subjects censored after stable disease
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Stable Disease (SD) Events
Number of Subjects with Stable Disease Events
|
22 participants
|
4 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
4 participants
|
0 participants
|
8 participants
|
|
Number of Subjects With Stable Disease (SD) Events
Number of Subjects with Progressive Disease or Death after Stable Disease
|
12 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
4 participants
|
0 participants
|
6 participants
|
|
Number of Subjects With Stable Disease (SD) Events
Number of Subjects Censored after Stable Disease
|
10 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsPopulation: Full Analysis Set Population
Median duration of stable disease (SD) in days for each cohort
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Number of Days of Stable Disease (SD)
|
220 days
Interval 113.0 to 376.0
|
173 days
Interval 41.0 to
4 out of 10 patients had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
|
22 days
Interval 22.0 to 22.0
|
589 days
1 out of 2 evaluable patients (total n=3) had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
|
288 days
1 out of 3 patients had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
|
30 days
1 out of 3 patients had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
|
281 days
1 out of 3 patients had a stable disease event. There was an insufficient number of events to calculate the upper or lower 95% confidence interval
|
159 days
Interval 57.0 to
2 out of 7 patients had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
|
NA days
Interval 115.0 to
1 out of 3 patients had a stable disease event, therefore the median and 95% confidence interval could not be calculated
|
136 days
Interval 11.0 to
3 out of 4 evaluable patients (total n=9) had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
|
152 days
Interval 27.0 to
4 out of 5 evaluable patients (total n=6) had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
|
NA days
0 out of 3 patients had a stable disease event, therefore the median and 95% confidence interval could not be calculated
|
28 days
Interval 11.0 to
8 out of 19 patients had a stable disease event. There was an insufficient number of events to calculate the upper 95% confidence interval
|
SECONDARY outcome
Timeframe: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsPopulation: Full Analysis Set Population
Number of subjects with progressive disease or death and number of subject censored.
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Progression-free Survival (PFS) Events
Number of Patients with Disease Progression or Death Events
|
24 participants
|
8 participants
|
1 participants
|
2 participants
|
3 participants
|
3 participants
|
3 participants
|
5 participants
|
2 participants
|
7 participants
|
4 participants
|
3 participants
|
15 participants
|
|
Number of Subjects With Progression-free Survival (PFS) Events
Number of Patients Censored
|
12 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsPopulation: Full Analysis Set Population
This outcome measure shows the median number of days of progression-free survival (PFS) for each cohort
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Number of Days of Progression-free Survival (PFS)
|
146 days
Interval 58.0 to 240.0
|
56 days
Interval 29.0 to 96.0
|
22 days
Interval 22.0 to 22.0
|
642 days
Interval 27.0 to
2 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
53 days
Interval 53.0 to
3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
56 days
Interval 43.0 to
3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
42 days
Interval 32.0 to
3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
52 days
Interval 29.0 to
5 out of 7 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
243 days
Interval 168.0 to
2 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
57 days
Interval 54.0 to
7 out of 9 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
258 days
Interval 53.0 to
4 out of 6 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
29 days
Interval 25.0 to
3 out of 3 patients had a duration of PFS timepoint recorded. There was an insufficient number of events to calculate the upper 95% confidence interval
|
55 days
Interval 37.0 to 57.0
|
SECONDARY outcome
Timeframe: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsPopulation: Full Analysis Set Population
Number of subjects with overall survival (OS) events in each cohort
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Overall Survival (OS) Events
Number of Subjects with Death Events
|
15 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
5 participants
|
0 participants
|
3 participants
|
14 participants
|
|
Number of Subjects With Overall Survival (OS) Events
Number of Subjects Censored
|
21 participants
|
9 participants
|
0 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
6 participants
|
1 participants
|
4 participants
|
6 participants
|
0 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 monthsPopulation: Full Analysis Set Population
Median number of days of overall survival (OS) for each cohort
Outcome measures
| Measure |
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
Phase 1, Cohort 2
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 Participants
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Number of Days of Overall Survival (OS)
|
274 days
Interval 163.0 to
15 out of 36 patients had a death event; 21 patients were censored. There was an insufficient number of events to calculate the upper 95% confidence interval
|
362 days
Interval 362.0 to 362.0
|
22 days
Interval 22.0 to 22.0
|
NA days
0 out of 3 patients had a death event; 3 patients were censored
|
157 days
Interval 115.0 to
2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
|
145 days
Interval 61.0 to
2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
|
42 days
Interval 32.0 to
2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
|
NA days
Interval 48.0 to
1 out of 7 patients had a death event; 6 patients were censored. There was an insufficient number of events to calculate the upper 95% confidence interval
|
243 days
Interval 210.0 to
2 out of 3 patients had a death event; 1 patient was censored. There was an insufficient number of events to calculate the upper 95% confidence interval
|
113 days
Interval 58.0 to
5 out of 9 patients had a death event; 4 patients were censored. There was an insufficient number of events to calculate the upper 95% confidence interval
|
NA days
0 out of 6 patients had a death event; 6 patients were censored
|
97 days
Interval 63.0 to
3 out of 3 patients had a death event. There was an insufficient number of events to calculate the upper 95% confidence interval
|
70 days
Interval 43.0 to 124.0
|
Adverse Events
Phase 1, Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1, Cohort 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1, Cohort 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1, Cohort 5
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1, Cohort 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1, Cohort 7
Serious events: 5 serious events
Other events: 9 other events
Deaths: 5 deaths
Phase 1, Cohort 8
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1, Cohort 9
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 2a, Cohort 10, Advanced Solid Tumors
Serious events: 14 serious events
Other events: 19 other events
Deaths: 14 deaths
Phase 2a, Cohort 11, Cholangiocarcinoma
Serious events: 20 serious events
Other events: 36 other events
Deaths: 15 deaths
Phase 2a, Cohort 12, Gall Bladder Carcinoma
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Phase 2a, Cohort 13, Urothelial Carcinoma
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1, Cohort 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1, Cohort 2
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
chest pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Hepatobiliary disorders
cholesystitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
ascites
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Blood and lymphatic system disorders
blood bilirubin increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
4/36 • Number of events 5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Reproductive system and breast disorders
vaginal hemorrhage
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
General disorders
pyrexia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
4/36 • Number of events 5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
blood creatinine increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Infections and infestations
pneumonia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
26.3%
5/19 • Number of events 5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.6%
2/36 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
pharyngeal hemorrhage
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
blood sodium increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Vascular disorders
hypotension
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
2/6 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory distress syndrome
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
gastrointestinal hemorrhage
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
General disorders
fatigue
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.5%
2/19 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.6%
2/36 • Number of events 2 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Cardiac disorders
transient ischemic attack
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Hepatobiliary disorders
bile duct obstruction
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Injury, poisoning and procedural complications
transfusion reaction
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Eye disorders
diplopia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
abdominal distention
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Metabolism and nutrition disorders
diabetic ketoacidosis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Hepatobiliary disorders
cholangitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
8.3%
3/36 • Number of events 5 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Infections and infestations
enterobacter sepsis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Infections and infestations
liver abscess
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Infections and infestations
sepsis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
blood glucose decreased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Infections and infestations
influenza
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Infections and infestations
lung infection
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Number of events 1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
Other adverse events
| Measure |
Phase 1, Cohort 2
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 2: 12mg/m2
FF-10502-01
|
Phase 1, Cohort 3
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 3: 18mg/m2
FF-10502-01
|
Phase 1, Cohort 4
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 4: 27mg/m2
FF-10502-01
|
Phase 1, Cohort 5
n=7 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 5: 40mg/m2
FF-10502-01
|
Phase 1, Cohort 6
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 6: 60mg/m2
FF-10502-01
|
Phase 1, Cohort 7
n=9 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 7: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 8
n=6 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 8: 135mg/m2
FF-10502-01
|
Phase 1, Cohort 9
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 9: 100mg/m2
FF-10502-01
|
Phase 2a, Cohort 10, Advanced Solid Tumors
n=19 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 10: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 11, Cholangiocarcinoma
n=36 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 11: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 12, Gall Bladder Carcinoma
n=10 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 12: 90mg/m2
FF-10502-01
|
Phase 2a, Cohort 13, Urothelial Carcinoma
n=1 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 13: 90mg/m2
FF-10502-01
|
Phase 1, Cohort 1
n=3 participants at risk
FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing for Cohort 1: 8mg/m2
FF-10502-01
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
fatigue
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
3/3 • Number of events 3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
55.6%
5/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
50.0%
3/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
47.4%
9/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
52.8%
19/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
50.0%
5/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
3/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
General disorders
pyrexia
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
44.4%
4/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
83.3%
5/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
26.3%
5/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
38.9%
14/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
30.0%
3/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
1/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
General disorders
mucosal inflammation
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
30.6%
11/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
1/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
General disorders
chills
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
50.0%
3/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.5%
2/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
6/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
71.4%
5/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
21.1%
4/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
36.1%
13/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
30.0%
3/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
constipation
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
22.2%
2/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
21.1%
4/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
25.0%
9/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
diarrhea
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
15.8%
3/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
25.0%
9/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
40.0%
4/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
21.1%
4/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
12/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
31.6%
6/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
22.2%
8/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
30.0%
3/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Skin and subcutaneous tissue disorders
pruritus
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
3/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
83.3%
5/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
31.6%
6/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
36.1%
13/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
1/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Skin and subcutaneous tissue disorders
rash
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
3/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
2/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
41.7%
15/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
44.4%
4/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
15.8%
3/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
22.2%
8/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
50.0%
5/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
blood potassium decreased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
2/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.5%
2/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
19.4%
7/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
2/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
4/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
44.4%
4/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
50.0%
3/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
31.6%
6/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
13.9%
5/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
22.2%
2/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
4/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Nervous system disorders
headache
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
2/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
2.8%
1/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Nervous system disorders
dizziness
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
28.6%
2/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.6%
2/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Nervous system disorders
neuropathy peripheral
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
5.3%
1/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
8.3%
3/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Blood and lymphatic system disorders
anemia
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
42.9%
3/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
22.2%
2/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
2/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
3/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
31.6%
6/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
25.0%
9/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
40.0%
4/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
14.3%
1/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
3/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
3/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
26.3%
5/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
58.3%
21/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
22.2%
2/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
42.1%
8/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
38.9%
14/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
30.0%
3/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
66.7%
2/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
blood bilirubin increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.5%
2/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
6/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
20.0%
2/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
50.0%
3/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.5%
2/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
30.6%
11/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
10.0%
1/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
1/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Infections and infestations
oral herpes
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
16.7%
1/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
1/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Psychiatric disorders
confusional state
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
11.1%
1/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
1/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
|
Investigations
international normalized ratio (INR) increased
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/7 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
33.3%
1/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/9 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/6 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/19 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/36 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/10 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
100.0%
1/1 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
0.00%
0/3 • Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Definitions of AE and/or SAEs are the same as defined above
|
Additional Information
Vice President of Clinical Operations and Development
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