Trial Outcomes & Findings for CAR T Cells in Mesothelin Expressing Cancers (NCT NCT03054298)
NCT ID: NCT03054298
Last Updated: 2025-04-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
7 years
Results posted on
2025-04-29
Participant Flow
Protocol specifies that a consented participant is an enrolled participant. 65 participants were consented. Of these, 34 were ineligible and 31 were eligible. Of the 31 eligible, one participant was never assigned to a cohort. This participant was withdrawn prior to assignment due to disease progression. The remaining 30 participants are detailed below.
Participant milestones
| Measure |
Cohort 1
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
0
|
6
|
8
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
0
|
2
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAR T Cells in Mesothelin Expressing Cancers
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
n=3 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
n=2 Participants
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
n=6 Participants
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
n=8 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
n=8 Participants
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
62.3 years
n=7 Participants
|
68.1 years
n=5 Participants
|
—
|
61.1 years
n=21 Participants
|
59.7 years
n=10 Participants
|
63.0 years
n=115 Participants
|
61.6 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
27 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
6 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
29 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
6 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
—
|
6 participants
n=21 Participants
|
8 participants
n=10 Participants
|
8 participants
n=115 Participants
|
30 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 7 yearsPopulation: Cohort 4 closed prematurely.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
n=3 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
n=2 Participants
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
n=2 Participants
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
n=6 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
n=6 Participants
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 7 yearsPopulation: Cohort 4 was permanently closed.
Progression is defined using RECIST V1.1 - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
n=3 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
n=2 Participants
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
n=2 Participants
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
n=6 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
n=6 Participants
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival
|
8.1 weeks
Interval 4.1 to 13.1
|
7 weeks
Interval 4.0 to 26.0
|
7.6 weeks
Interval 0.7 to 14.4
|
—
|
13.5 weeks
Interval 11.0 to 16.0
|
14.1 weeks
Interval 8.4 to 96.0
|
12.3 weeks
Interval 4.0 to 22.3
|
SECONDARY outcome
Timeframe: 7 yearsPopulation: Cohort 4 was prematurely closed.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
n=3 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
n=2 Participants
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
n=2 Participants
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
n=6 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
n=6 Participants
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
14.6 weeks
Interval 8.2 to 58.9
|
129.6 weeks
Interval 9.7 to 145.7
|
57.9 weeks
Interval 0.7 to 115.0
|
—
|
65.2 weeks
Interval 49.3 to 81.1
|
81.1 weeks
Interval 9.4 to 118.0
|
22 weeks
Interval 18.3 to 32.4
|
SECONDARY outcome
Timeframe: Month 6Population: Cohort 4 was permanently closed.
Objective response rate is the proportion of subjects in the efficacy-evaluable set with radiologically confirmed measurable disease at baseline, who achieved partial response (PR) or better after infusion as determined by RECIST 1.1. Missing or non-evaluable time points will not be included. Per RECIST 1.1, a complete response is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm." A partial response is defined as "at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
n=3 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
n=2 Participants
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
n=2 Participants
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
n=6 Participants
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
n=6 Participants
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 3
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Cohort 6
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort 7
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
n=3 participants at risk
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
n=2 participants at risk
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
n=2 participants at risk
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
n=6 participants at risk
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
n=6 participants at risk
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Other (Viral gastroenteritis)
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Edema limbs
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Fatigue
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Fever
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Other (disease progression)
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Infections and infestations
Cytokine release syndrome
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Infections and infestations
Other (COVID-19)
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Other (CAR Neurotoxicity)
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Other (possible drug withdrawal)
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
100.0%
2/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 2
n=3 participants at risk
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 3
n=2 participants at risk
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 4
PERMANENTLY CLOSED
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 5
n=2 participants at risk
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 6
n=6 participants at risk
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
Cohort 7
n=6 participants at risk
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells.
huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
100.0%
6/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Eye disorders
Other (anisocoria)
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Eye disorders
Other (burning sensation)
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Other (Pain RUQ)
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
83.3%
5/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
83.3%
5/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Stomach pain
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Chills
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Edema limbs
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Fatigue
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Fever
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Malaise
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
General disorders
Pain
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Hepatobiliary disorders
Hepatic pain
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Injury, poisoning and procedural complications
Other (Drug overdose)
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Alanine animotransferase increased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
INR increased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
100.0%
3/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
100.0%
6/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
100.0%
6/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
Weight loss
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
100.0%
3/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
83.3%
5/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
83.3%
5/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
83.3%
5/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
83.3%
5/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
3/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Headache
|
100.0%
3/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Paresthesia
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Renal and urinary disorders
Urine discoloration
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
3/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
66.7%
4/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
50.0%
1/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Skin and subcutaneous tissue disorders
Other (goose bumpy feeling)
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Vascular disorders
Hot flashes
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/3 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
—
0/0 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
0.00%
0/2 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
33.3%
2/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
16.7%
1/6 • 7 years
Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place