Trial Outcomes & Findings for Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC (NCT NCT03042468)

Last Updated: 2025-09-17

Results Overview

Proportion of subjects experiencing a dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 by using 3+3 dose escalation was assessed.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Assessed throughout the DLT period, up to 92 days after starting study drug.

Results posted on

2025-09-17

Participant Flow

Recruitment took place at at Weill Cornell Medicine New York Presbyterian and Tulane Medical Center.

Participant milestones

Participant milestones
Measure	177Lu-PSMA-617 Cohort 1 Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	Dose Expansion Cohort Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.
Overall Study STARTED	6	6	5	6	6	21
Overall Study COMPLETED	6	5	4	6	5	19
Overall Study NOT COMPLETED	0	1	1	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	177Lu-PSMA-617 Cohort 2 Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	Dose Expansion Cohort Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.
Overall Study Death	1	1	0	0
Overall Study Withdrawal by Subject	0	0	0	1
Overall Study Lost to Follow-up	0	0	1	1

Baseline Characteristics

Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants	4 Participants n=10 Participants	10 Participants n=115 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	3 Participants n=36 Participants	17 Participants n=10 Participants	40 Participants n=115 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	21 Participants n=10 Participants	50 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	19 Participants n=10 Participants	43 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants

PRIMARY outcome

Timeframe: Assessed throughout the DLT period, up to 92 days after starting study drug.

Proportion of subjects experiencing a dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 by using 3+3 dose escalation was assessed.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Number of Subjects With Dose Limiting Toxicity (DLT) of Fractionated Dose of 177Lu-PSMA-617	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: from first dose of study drug to at least 12 weeks of subsequent follow-up evaluations, up to 92 days

This outcome is measuring the number of subjects that achieved MTD. MTD is defined as the highest dose level with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. If no DLTs were experienced, then a recommended phase II dose was determined in 2-wk dose-fractionation regimen by using a 3+3 dose escalation design, as no MTD was observed.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Number of Subjects That Achieved Cumulative Maximum Tolerated Dose (MTD) Phase II Dose of 177Lu-PSMA-617	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Duration of Phase I, up to 47 months

Recommended Phase II dose was determined based on the results of the Phase I portion of the study. Since no Maximum Tolerated Dose was achieved given that no Dose Limiting Toxicities occurred, the Recommended Phase II dose was determined based on the Cohort 5 dose.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=29 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Recommended Phase II Dose of 177Lu-PSMA-617 in a 2-week Dose-fractionation Regimen	—	300 mci	—	—	—	—

SECONDARY outcome

Timeframe: from baseline visit to short term follow up visit, approximately 6 months

Proportion of patients with PSA decline following treatment (fractionated 177Lu-PSMA-617) with the RP2D of fractionated dose 177Lu-PSMA-617 (Phase II). PSA response will be determined by comparing the PSA levels after therapy to the baseline, pre-treatment PSA.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
The Rate of PSA Decline Following Fractionated 177Lu-PSMA-617	21 Participants	5 Participants	3 Participants	3 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: From start of study to progression of disease with at least 12 weeks of subsequent follow-up evaluations, up to 54 months

Population: Only evaluable subjects were analyzed for this measure.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=5 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=1 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=1 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=4 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Count of Patients That Had a Radiographic Response Rate Measured by RECIST 1.1 With PCWG3 Modifications	3 Participants	4 Participants	0 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Duration of time on study, from baseline to last follow up visit, up to 54 months

Progression Free Survival, with progression determined based by Radiographic and Biochemical response. Biochemical response was assessed by comparing the PSA levels after therapy to the baseline, pre-treatment PSA. Declines of ≥ 30% confirmed by a second PSA value ≥2 weeks later, are reported.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Progression-free Survival Measured by PCWG3 (Prostate Cancer Working Group3) Criteria	176 days Interval 14.0 to 1145.0	95 days Interval 42.0 to 118.0	147 days Interval 14.0 to 429.0	119 days Interval 14.0 to 357.0	188 days Interval 83.0 to 449.0	99 days Interval 13.0 to 265.0

SECONDARY outcome

Timeframe: Duration of study, from screening to EOS visit, up to 12 weeks

Changes in CTC count as measured by CellSearch and the rate of favorable CTC count and LDH at 12 weeks following fractionated 177Lu-PSMA-617. All subjects in this study will get blood samples drawn (at screening and EOS visit) for CTC enumeration by CellSearch methodology. Participants whose CTC counts drop to less than 5 or stay below 5 (responders) vs. those who remain at least 5 or above (non-responders) at EOS visit are analyzed.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Number of CTC Count Responders	21 Participants	4 Participants	4 Participants	4 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Overall survival was defined as the time from start of 177Lu-PSMA-617 to the date of death from any cause, or last date of follow up.

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Overall Survival Following Fractionated 177Lu-PSMA-617	478 days Interval 110.0 to 1617.0	385 days Interval 156.0 to 554.0	607 days Interval 57.0 to 1471.0	368 days Interval 51.0 to 763.0	743 days Interval 248.0 to 1595.0	409 days Interval 84.0 to 751.0

SECONDARY outcome

Timeframe: From screening to end of study visit, up to 54 months

Outcome measures

Outcome measures
Measure	Dose Expansion Cohort n=21 Participants Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.	177Lu-PSMA-617 Cohort 1 n=6 Participants Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 Participants Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 Participants Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 Participants Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 Participants Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment
Count of Participants That Experience an Adverse Event	21 Participants	6 Participants	6 Participants	5 Participants	6 Participants	6 Participants

Adverse Events

177Lu-PSMA-617 Cohort 1

Serious events: 1 serious events

Other events: 6 other events

Deaths: 6 deaths

177Lu-PSMA-617 Cohort 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 6 deaths

177Lu-PSMA-617 Cohort 3

Serious events: 2 serious events

Other events: 5 other events

Deaths: 5 deaths

177Lu-PSMA-617 Cohort 4

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

177Lu-PSMA-617 Cohort 5

Serious events: 0 serious events

Other events: 6 other events

Deaths: 6 deaths

Dose Expansion Cohort

Serious events: 3 serious events

Other events: 21 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	177Lu-PSMA-617 Cohort 1 n=6 participants at risk Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 participants at risk Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 participants at risk Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 participants at risk Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 participants at risk Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	Dose Expansion Cohort n=21 participants at risk Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.
Blood and lymphatic system disorders Bacteremia	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	4.8% 1/21 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Musculoskeletal and connective tissue disorders Lower Extremity Weakness	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	4.8% 1/21 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Death due to disease progression	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Infections and infestations Sepsis	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	4.8% 1/21 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.

Other adverse events

Other adverse events
Measure	177Lu-PSMA-617 Cohort 1 n=6 participants at risk Cohort 1: Participants were administered of 177Lu-PSMA-617 once at the dose level of 50mCi (1.85GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 2 n=6 participants at risk Cohort 2: Participants were administered of 177Lu-PSMA-617 once at the dose level of 100mCi (3.7GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 3 n=5 participants at risk Cohort 3: Participants were administered of 177Lu-PSMA-617 once at the dose level of 200mCi (7.4GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 4 n=6 participants at risk Cohort 4: Participants were administered of 177Lu-PSMA-617 once at the dose level of 250mCi (9.25GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	177Lu-PSMA-617 Cohort 5 n=6 participants at risk Cohort 5: Participants were administered of 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment	Dose Expansion Cohort n=21 participants at risk Participants followed Cohort 5 and were administered 177Lu-PSMA-617 once at the dose level of 300mCi (11.1GBq) via intravenous infusion (IV) in two doses two weeks apart at Visits 1 and 2. Participants were then followed until death for survival assessment.
Blood and lymphatic system disorders Neutropenia	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	23.8% 5/21 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders Anemia	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 5/5 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	81.0% 17/21 • Number of events 17 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	80.0% 4/5 • Number of events 4 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	19.0% 4/21 • Number of events 4 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Xerostemia	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	83.3% 5/6 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	40.0% 2/5 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	66.7% 14/21 • Number of events 14 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Pain	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 5/5 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	83.3% 5/6 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	90.5% 19/21 • Number of events 19 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Fatigue	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 5/5 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 6/6 • Number of events 6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	90.5% 19/21 • Number of events 19 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Nausea	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	60.0% 3/5 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	66.7% 4/6 • Number of events 4 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	66.7% 14/21 • Number of events 14 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders AST increased	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	80.0% 4/5 • Number of events 4 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	23.8% 5/21 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders High Creatinine	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	60.0% 3/5 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 7/21 • Number of events 7 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Gastrointestinal disorders Abdominal distention	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders ALP increased	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders ALT increased	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	100.0% 5/5 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	23.8% 5/21 • Number of events 5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Musculoskeletal and connective tissue disorders Arthralgias	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Respiratory, thoracic and mediastinal disorders Asthma	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Bells palsy	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Respiratory, thoracic and mediastinal disorders Bronchial infection	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Constipation	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Cough	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	50.0% 3/6 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Death due to progression	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Eye disorders Diplopia	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Dizziness	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Eye disorders Dry eyes	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Dysarthria	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Dysguesia	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	14.3% 3/21 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Edema	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Epistaxis	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Facial trauma	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Fall	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Fever	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	20.0% 1/5 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Gastrointestinal disorders Heartburn	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders Hypoalbuminenia	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders Hypocalcemia	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders Hypokalemia	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Cardiac disorders Hypotension	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders Lymphocyte count decreased	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	33.3% 2/6 • Number of events 2 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Musculoskeletal and connective tissue disorders Muscle weakness LL	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Nasal congestion	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Nervous system disorders Neuropathy	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	60.0% 3/5 • Number of events 3 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Nocturia	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Musculoskeletal and connective tissue disorders Peritendinitis	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Skin and subcutaneous tissue disorders Skin lesion	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
General disorders Sore throat	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Metabolism and nutrition disorders Weight loss	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Blood and lymphatic system disorders Leukopenia (white blood cell count decreased)	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	16.7% 1/6 • Number of events 1 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/5 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/6 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.	0.00% 0/21 • Adverse events collected during the duration of the study, from start of study to end of study, up to 5 years. Patients who passed away during the follow up period were also included.

Additional Information

Dr. Scott Tagawa

Weill Cornell Medicine

Phone: 646-962-2027

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place