Trial Outcomes & Findings for Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC (NCT NCT04506567)
NCT ID: NCT04506567
Last Updated: 2026-08-19
Results Overview
DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Collected from Day 1 through 6 months
Results posted on
2026-08-19
Participant Flow
Participants were enrolled in Phase I of the study only. Phase II of the study was never initiated.
Participants were enrolled in parallel to the Multiple Dose and Fractionated Dose (without prior 177Lu-PSMA-RL) regimen cohorts first, then participants were enrolled in an expansion Fractionated Dose Post 177Lu-PSMA-RL cohort. Data are reported for Phase I, as Phase II was never initiated and will not be initiated.
Participant milestones
| Measure |
Phase I: Multiple Dose 45 KBq/kg
Participants enrolled in this multiple dose regimen cohort received 45 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Multiple Dose 55 KBq/kg
Participants enrolled in this multiple dose regimen cohort received 55 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Multiple Dose 65 KBq/kg
Participants enrolled in this multiple dose regimen cohort received 65 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Fractionated Dose 45 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 45 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Fractionated Dose 55 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 55 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Fractionated Dose 60 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 60 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
Note that this group includes both the dose-escalation portion of the fractionated dose of 60 KBq/kg and the subsequent dose-expansion (Phase I) portion of fractionated-dose 60 KBq/kg.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Fractionated Dose 65 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 65 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Fractionated Dose Post 177Lu-PSMA-RL 45 KBq/kg
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
Phase I: Fractionated Dose Post 177Lu-PSMA-RL 50 KBq/kg
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
The participants also received 68Ga-PSMA-HBED-CC injection: 68Ga-PSMA-HBED-CC PET/CT before and after treatment.
|
|---|---|---|---|---|---|---|---|---|---|
|
Phase I: Multiple Dose 45 KBq/kg
STARTED
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 45 KBq/kg
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 45 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 55 KBq/kg
STARTED
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 55 KBq/kg
COMPLETED
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 55 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 65 KBq/kg
STARTED
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 65 KBq/kg
COMPLETED
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Multiple Dose 65 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 45 KBq/kg
STARTED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 45 KBq/kg
COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 45 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 55 KBq/kg
STARTED
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 55 KBq/kg
COMPLETED
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 55 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 60 KBq/kg
STARTED
|
0
|
0
|
0
|
0
|
0
|
18
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 60 KBq/kg
Dose escalation portion
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 60 KBq/kg
Dose expansion (Phase I)
|
0
|
0
|
0
|
0
|
0
|
11
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 60 KBq/kg
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
18
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 60 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I: Fractionated Dose 65 KBq/kg
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Phase I: Fractionated Dose 65 KBq/kg
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Phase I: Fractionated Dose 65 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ph1:Fractionated Post 177Lu 45 KBq/kg
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Ph1:Fractionated Post 177Lu 45 KBq/kg
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Ph1:Fractionated Post 177Lu 45 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Ph1:Fractionated Post 177Lu 50 KBq/kg
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Ph1:Fractionated Post 177Lu 50 KBq/kg
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Ph1:Fractionated Post 177Lu 50 KBq/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC
Baseline characteristics by cohort
| Measure |
Fractionated Dose 65 KBq/kg
n=6 Participants
Participant in this cohort receive a single cycle of 65 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Multiple Dose 45 KBq/kg
n=6 Participants
Participants in this multiple dose cohort received 45 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=6 Participants
Participants in this multiple dose cohort received 55 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=6 Participants
Participants in this multiple dose cohort received 65 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
n=3 Participants
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
n=7 Participants
Participants in this cohort received a single cycle of 55 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 60 KBq/kg
n=18 Participants
Participants in this cohort receive a single cycle of 60 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose (Prior 177Lu-PSMA-RL) 45 KBq/kg
n=2 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose (Prior 177Lu-PSMA-RL) 50 KBq/kg
n=6 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
75 years
n=44 Participants
|
74 years
n=298 Participants
|
68 years
n=102 Participants
|
72 years
n=400 Participants
|
69 years
n=30 Participants
|
72 years
n=1389 Participants
|
77 years
n=44 Participants
|
80 years
n=97 Participants
|
73 years
n=23 Participants
|
73 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=44 Participants
|
6 Participants
n=298 Participants
|
6 Participants
n=102 Participants
|
6 Participants
n=400 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=1389 Participants
|
18 Participants
n=44 Participants
|
2 Participants
n=97 Participants
|
6 Participants
n=23 Participants
|
60 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=44 Participants
|
6 Participants
n=298 Participants
|
5 Participants
n=102 Participants
|
6 Participants
n=400 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=1389 Participants
|
14 Participants
n=44 Participants
|
2 Participants
n=97 Participants
|
5 Participants
n=23 Participants
|
53 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=1389 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
4 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=44 Participants
|
2 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
2 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=1389 Participants
|
4 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
10 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=44 Participants
|
4 Participants
n=298 Participants
|
5 Participants
n=102 Participants
|
4 Participants
n=400 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=1389 Participants
|
14 Participants
n=44 Participants
|
1 Participants
n=97 Participants
|
5 Participants
n=23 Participants
|
45 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=97 Participants
|
1 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Collected from Day 1 through 6 monthsPopulation: For the Fractionated Dose 60 KBq/kg group, only the participants that were enrolled in the dose escalation portion were analyzed. In this dose escalation portion, 6 participants were analyzed instead of the 7 enrolled because 1 patient did not receive day 15 fractionated dose due to non-toxicity reasons and was deemed unevaluable for DLT. Participants in the Dose Expansion (Phase I) arm were not assessed for DLTs.
DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Multiple Dose 45 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 45 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 55 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 65 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
n=3 Participants
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
n=7 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 55 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose 60 KBq/kg
n=6 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 60 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
This is the same dose regimen used for the expansion cohort of fractionated-dose 225Ac-J591.
|
Fractionated Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 65 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 45 KBq/kg
n=2 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 50 KBq/kg
n=6 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Collected from Day 1 through 6 monthsPopulation: This dose expansion cohort generated additional safety and preliminary efficacy data. MTD was not assessed in this cohort.
The dose that produces an "acceptable" level of toxicity or that, if exceeded, would put subjects at "unacceptable" risk for toxicity. MTD is defined as the dose level at which no more than two patients out of six experienced dose-limiting toxicity (DLT).
Outcome measures
| Measure |
Multiple Dose 45 KBq/kg
n=22 Participants
Participants enrolled in this multiple dose regimen cohort received 45 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=8 Participants
Participants enrolled in this multiple dose regimen cohort received 55 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=18 Participants
Participants enrolled in this multiple dose regimen cohort received 65 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 55 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose 60 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 60 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
This is the same dose regimen used for the expansion cohort of fractionated-dose 225Ac-J591.
|
Fractionated Dose 65 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 65 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 45 KBq/kg
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 50 KBq/kg
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
60 KBq/kg
|
NA KBq/kg
The MTD is defined as the highest dose level with an observed occurrence of DLT in no more than 1 out of 6 patients treated at that dose level. For this fractionated-dose regimen post 177Lu-PSMA-RL cohort, there were 2 DLTs at the first dose level. Then, since only 2 additional participants were enrolled to the second dose level prior to study closure, no MTD could be determined.
|
NA KBq/kg
For the multiple-dose regimen, there were DTLs at every dose level, thus the criteria was not met to determine a MTD.
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Collected from Day 1 through 6 monthsPopulation: The Expansion cohort of fractionated dose regimen was a dose expansion cohort that generated additional safety and preliminary efficacy data. RP2D was not assessed in this cohort.
Outcome measures
| Measure |
Multiple Dose 45 KBq/kg
n=22 Participants
Participants enrolled in this multiple dose regimen cohort received 45 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=8 Participants
Participants enrolled in this multiple dose regimen cohort received 55 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=18 Participants
Participants enrolled in this multiple dose regimen cohort received 65 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 55 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose 60 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 60 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
This is the same dose regimen used for the expansion cohort of fractionated-dose 225Ac-J591.
|
Fractionated Dose 65 KBq/kg
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 65 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 45 KBq/kg
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 50 KBq/kg
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Recommended Phase II Dose (RP2D) of 225Ac-J591 in Fractionated Dose and Multiple Dose Regimens Both Pre- and Post-treatment With 177Lu-PSMA-RL
|
60 KBq/kg
|
NA KBq/kg
The R2PD is determined at the dose level with an observed occurrence of DLT in no more than 1 out of 6 patients treated at that dose level. For this fractionated-dose regimen post 177Lu-PSMA-RL cohort, there were 2 DLTs at the first dose level. Then, since only two additional participants were enrolled to the second dose level prior to study closure, no R2PD could be determined.
|
NA KBq/kg
For the multiple-dose regimen, there were DTLs at every dose level, thus the criteria was not met to determine a RP2D.
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Collected from Day 1 through 6 monthsNumber of participants achieving greater than 50% PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy
Outcome measures
| Measure |
Multiple Dose 45 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 45 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 55 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 65 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
n=3 Participants
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
n=7 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 55 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose 60 KBq/kg
n=18 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 60 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
This is the same dose regimen used for the expansion cohort of fractionated-dose 225Ac-J591.
|
Fractionated Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 65 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 45 KBq/kg
n=2 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 50 KBq/kg
n=6 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With PSMA-positive Tumors With >50% PSA Decline Following 225Ac-J591 in Each Cohort Regimen
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Imaging performed at timepoints from Day 1 through study completion, approximately 3 years.Response evaluation criteria in solid tumors RECIST (Version 1.1) criteria with prostate cancer working group 3 (PCWG3) modifications to be used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Collected from Day 1 through study completion, approximately 3 years.Overall survival will be captured through in-clinic or telephone contact with participants
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Scans performed during screening period (within 30 days of Cycle 1 Day 1) and at Day 85 from Cycle 1 Day 1.Population: For the 2 participants that were enrolled in the Fractionated Dose (Prior 177Lu-PSMA-RL) 45 KBq/kg cohort, the Day 85 PSMA PET/CT was not performed.
Change in Maximum SUV (SUVmax) from Baseline 68Ga-PSMA-11 PET/CT to Post-therapy (Week 12) 68Ga-PSMA-11 PET/CT. 68Ga-PSMA-11 PET/CT was utilized as part of the radiographic assessment.
Outcome measures
| Measure |
Multiple Dose 45 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 45 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 55 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 65 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
n=3 Participants
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
n=7 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 55 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose 60 KBq/kg
n=18 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 60 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
This is the same dose regimen used for the expansion cohort of fractionated-dose 225Ac-J591.
|
Fractionated Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 65 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 45 KBq/kg
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 50 KBq/kg
n=6 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Disease Assessment With 68Ga-PSMA-11 PET/CT Prior to and Following Investigational Treatment
|
-9 standardized uptake values (SUV)
Interval -24.0 to -2.0
|
-22 standardized uptake values (SUV)
Interval -22.0 to -22.0
|
-16 standardized uptake values (SUV)
Interval -39.0 to 4.0
|
-1 standardized uptake values (SUV)
Interval -4.0 to 1.0
|
-2 standardized uptake values (SUV)
Interval -12.0 to -1.0
|
-4 standardized uptake values (SUV)
Interval -18.0 to -1.0
|
-4 standardized uptake values (SUV)
Interval -38.0 to -2.0
|
—
|
-4 standardized uptake values (SUV)
Interval -25.0 to 10.0
|
SECONDARY outcome
Timeframe: Samples will be collected at Screening and Day 85CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing. Number of participants with changes in CTC count.
Outcome measures
| Measure |
Multiple Dose 45 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 45 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 55 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this multiple dose regimen cohort received 65 KBq/kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
n=3 Participants
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
n=7 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 55 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose 60 KBq/kg
n=18 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 60 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
This is the same dose regimen used for the expansion cohort of fractionated-dose 225Ac-J591.
|
Fractionated Dose 65 KBq/kg
n=6 Participants
Participants enrolled in this fractionated dose regimen cohort received a single cycle of 65 KBq/kg of 225Ac-J591 as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 45 KBq/kg
n=2 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
Fractionated Dose Post 177Lu-PSMA-RL 50 KBq/kg
n=6 Participants
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on day 1 and day 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change in Circulating Tumor Cells (CTC) Count at 12 Weeks Following 225Ac-J591
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Collected from Day 1 through study completion, approximately 3 yearsNational Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Collected from Day 1 through study completion, approximately 3 yearsPSA progression will be defined as a rise of \> 25% above either the pretreatment level or the nadir PSA level (whichever is lowest). PSA must increase by \> 2 ng/ml to be considered progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Collected from Day 1 through study completion, approximately 3 yearsPSA will be monitored through serial blood draws. Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.
Outcome measures
Outcome data not reported
Adverse Events
Multiple Dose 45 KBq/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
Multiple Dose 55 KBq/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
Multiple Dose 65 KBq/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
Fractionated Dose 45 KBq/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Fractionated Dose 55 KBq/kg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 7 deaths
Fractionated Dose 60 KBq/kg
Serious events: 5 serious events
Other events: 18 other events
Deaths: 17 deaths
Fractionated Dose 65 KBq/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 5 deaths
Fractionated Dose (Prior 177Lu-PSMA-RL) 45 KBq/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Fractionated Dose (Prior 177Lu-PSMA-RL) 50 KBq/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Multiple Dose 45 KBq/kg
n=6 participants at risk
Participants in this multiple dose cohort received 45 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=6 participants at risk
Participants in this multiple dose cohort received 55 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=6 participants at risk
Participants in this multiple dose cohort received 65 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
n=3 participants at risk
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
n=7 participants at risk
Participants in this cohort received a single cycle of 55 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 60 KBq/kg
n=18 participants at risk
Participants in this cohort receive a single cycle of 60 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 65 KBq/kg
n=6 participants at risk
Participant in this cohort receive a single cycle of 65 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose (Prior 177Lu-PSMA-RL) 45 KBq/kg
n=2 participants at risk
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose (Prior 177Lu-PSMA-RL) 50 KBq/kg
n=6 participants at risk
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Cardiac disorders
Atrioventricular block complete
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
Other adverse events
| Measure |
Multiple Dose 45 KBq/kg
n=6 participants at risk
Participants in this multiple dose cohort received 45 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 55 KBq/kg
n=6 participants at risk
Participants in this multiple dose cohort received 55 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Multiple Dose 65 KBq/kg
n=6 participants at risk
Participants in this multiple dose cohort received 65 KBq/Kg of 225Ac-J591 every 6 weeks, up to 4 cycles.
|
Fractionated Dose 45 KBq/kg
n=3 participants at risk
Participants in this cohort received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 55 KBq/kg
n=7 participants at risk
Participants in this cohort received a single cycle of 55 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 60 KBq/kg
n=18 participants at risk
Participants in this cohort receive a single cycle of 60 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose 65 KBq/kg
n=6 participants at risk
Participant in this cohort receive a single cycle of 65 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose (Prior 177Lu-PSMA-RL) 45 KBq/kg
n=2 participants at risk
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 45 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
Fractionated Dose (Prior 177Lu-PSMA-RL) 50 KBq/kg
n=6 participants at risk
Participants in this cohort, who were previously treated with 177Lu-PSMA-RL, received a single cycle of 50 KBq/kg of 225Ac-J591, administered as a fractionated dose on days 1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
3/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
85.7%
6/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
15/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
2/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Investigations
Weight Loss
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
42.9%
3/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
12/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
General disorders
Fatigue
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
2/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
85.7%
6/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
55.6%
10/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
3/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
71.4%
5/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
55.6%
10/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Investigations
Transaminitis
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
85.7%
6/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
77.8%
14/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
2/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
General disorders
Pain
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
2/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
57.1%
4/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
55.6%
10/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
28.6%
2/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
12/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Nausea or vomiting
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
2/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
42.9%
3/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
61.1%
11/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea or Hypoxemia
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
42.9%
3/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
12/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Dry Mouth
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
57.1%
4/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
61.1%
11/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
28.6%
2/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
12/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Low appetite
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
100.0%
6/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
57.1%
4/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
44.4%
8/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
83.3%
5/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
38.9%
7/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Investigations
Alkaline phosphatase elevation
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
28.6%
2/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
55.6%
10/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Renal and urinary disorders
Urinary frequency, urgency or incontinence
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
28.6%
2/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
22.2%
4/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
General disorders
Gait disturbance or Motor weakness
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
28.6%
2/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
9/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
28.6%
2/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
22.2%
4/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Electrolyte abnormalities
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
9/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
6/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
General disorders
Edema/Swelling
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
38.9%
7/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
2/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
57.1%
4/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Psychiatric disorders
Sleep disturbance
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
3/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
22.2%
4/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
66.7%
4/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
6/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
22.2%
4/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
38.9%
7/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
6/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
28.6%
2/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Nervous system disorders
Peripheral neuropathy or Paresthesia
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
3/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
General disorders
Chills
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
22.2%
4/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
3/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
General disorders
Fever
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
27.8%
5/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Eye disorders
Dry eye or eye irritation
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
1/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
27.8%
5/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
50.0%
3/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
3/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Investigations
Weight gain
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
11.1%
2/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
14.3%
1/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
5.6%
1/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
1/3 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/7 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/18 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
33.3%
2/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/2 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
0.00%
0/6 • Adverse event and All-Cause Mortality data was collected from start of treatment to off study date, approximately 3 years. Serious adverse event data was collected from start of treatment to date of progression, up to approximately 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place