Trial Outcomes & Findings for Yttrium Y 90 Ibritumomab Tiuxetan, Etoposide, Cyclophosphamide, and an AHSCT in Non-Hodgkin's Lymphoma Patients (NCT NCT00562978)

NCT ID: NCT00562978

Last Updated: 2021-06-18

Results Overview

Complete response is defined as complete disappearance of all measureable evidence of non-evaluable disease. No new lesions. No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. All measureable, evaluable and non-evaluable lesions and sites must be assessed using the same techniques as baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: Assessed up to 5 years post-ASCT
• Results posted on: 2021-06-18

Participant Flow

Participant milestones

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10\^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. filgrastim cyclophosphamide etoposide AHSCT yttrium Y 90 ibritumomab tiuxetan	Zevalin 1000 cGy + VP-16 60 mg/kg + * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10\^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. filgrastim cyclophosphamide etoposide AHSCT yttrium Y 90 ibritumomab tiuxetan
Overall Study STARTED	6	48
Overall Study COMPLETED	5	37
Overall Study NOT COMPLETED	1	11

Reasons for withdrawal

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10\^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. filgrastim cyclophosphamide etoposide AHSCT yttrium Y 90 ibritumomab tiuxetan	Zevalin 1000 cGy + VP-16 60 mg/kg + * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10\^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. filgrastim cyclophosphamide etoposide AHSCT yttrium Y 90 ibritumomab tiuxetan
Overall Study Patient had imaging dose only	1	11

Baseline Characteristics

Yttrium Y 90 Ibritumomab Tiuxetan, Etoposide, Cyclophosphamide, and an AHSCT in Non-Hodgkin's Lymphoma Patients

Baseline characteristics by cohort

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg n=6 Participants * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10\^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. filgrastim cyclophosphamide etoposide AHSCT yttrium Y 90 ibritumomab tiuxetan	Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg n=48 Participants * Preparation for AHSCT: Peripheral blood stem cells (PBSCs) are collected via leukapheresis. Samples are analyzed by cytogenetic studies, immunophenotyping, and gene rearrangement. Patients with an adequate number of collected CD34-positive cells (≥ 3 times 10\^6 /kg) proceed to radioimmunotherapy. * Radioimmunotherapy: Patients receive yttrium Y 90 ibritumomab tiuxetan and undergo bone marrow biopsy and dose estimation. * Chemotherapy: Patients receive etoposide IV and cyclophosphamide IV * AHSCT: Patients undergo reinfusion of PBSCs. * Growth factor therapy: Patients receive filgrastim (G-CSF) IV. Treatment continues in the absence of disease progression or unacceptable toxicity. filgrastim cyclophosphamide etoposide AHSCT yttrium Y 90 ibritumomab tiuxetan	Total n=54 Participants Total of all reporting groups
Age, Continuous	54 Years n=5 Participants	50 Years n=7 Participants	50 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	28 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	43 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	48 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed up to 5 years post-ASCT

Population: Patients had favorable bio-distribution on imaging dose and received the study treatment.

Complete response is defined as complete disappearance of all measureable evidence of non-evaluable disease. No new lesions. No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. All measureable, evaluable and non-evaluable lesions and sites must be assessed using the same techniques as baseline.

Outcome measures

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg n=5 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.	Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg n=37 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
Number of Patients Achieving Complete Response (CR)	4 Participants	32 Participants

PRIMARY outcome

Timeframe: From initial of study treatment to Day 100 post-ASCT

Population: Patients had favorable bio-distribution on imaging dose and received the study treatment.

The NCI Common Toxicity Criteria (CTC Version 2.0) are used. The patients, whose toxicities are grade 3 or greater and at possibly related to the study treatment, are reported.

Outcome measures

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg n=5 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.	Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg n=37 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
Number of Patients With Grade 3 or Greater Toxicity	5 Participants	37 Participants

PRIMARY outcome

Timeframe: From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years

Population: Patients had favorable bio-distribution on imaging dose and received the study treatment

Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]

Outcome measures

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg n=5 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.	Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg n=37 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
5-Year Overall Survival (Phase II)	60 percentage of probability Interval 13.0 to 88.0	86 percentage of probability Interval 71.0 to 94.0

PRIMARY outcome

Timeframe: From peripheral stem cell infusion (Day0 ASCT) to first observation of relapse or death due to any cause, whichever comes first, assessed up to 5 years

Population: Patients had favorable bio-distribution on imaging dose and received the study treatment

Disease-free survival (DFS) was defined as time from peripheral stem cell infusion to relapse or death. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Disease-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.]

Outcome measures

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg n=5 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.	Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg n=37 Participants Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
5-Year Disease-free Survival (Phase II)	60 percentage of probability Interval 13.0 to 88.0	62 percentage of probability Interval 45.0 to 76.0

Adverse Events

Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg

Serious events: 5 serious events

Other events: 5 other events

Deaths: 3 deaths

Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg

Serious events: 20 serious events

Other events: 37 other events

Deaths: 15 deaths

Serious adverse events

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg n=5 participants at risk Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.	Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg n=37 participants at risk Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Investigations Failure to engraft	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Blood/Bone Marrow - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Bone marrow cellularity	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Leukocytes (total WBC)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Platelets	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Cardiac Arrhythmia - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Supraventricular and nodal arrhythmia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Cardiac General - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Hypotension	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Left ventricular systolic dysfunction	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 8 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Edema	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Fatigue (asthenia, lethargy, malaise)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Extensive Skin Rash	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Specify, __)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	0.00% 0/37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Pruritus/itching	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Endocrine disorders Endocrine - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Anorexia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Dehydration	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Gastrointestinal - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Febrile neutropenia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection with unknown ANC	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Herpes Zoster (COH)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	0.00% 0/37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection with grade 3 or 4 neutropenia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection without neutropenia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection, Bacterial (COH)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection, Fungal (COH)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection, Viral (COH)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Creatinine	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Neurology - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis (radiographic changes)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	0.00% 0/37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Investigations Secondary Malignancy - possibly related to cancer treatment (Specify, __)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	21.6% 8/37 • Number of events 11 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.

Other adverse events

Measure	Zevalin 1000 cGy + VP-16 40 mg/kg + Cytoxan 100 mg/kg n=5 participants at risk Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 40 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.	Zevalin 1000 cGy + VP-16 60 mg/kg + Cytoxan 100 mg/kg n=37 participants at risk Zevalin to deliver 1000 cGy highest normal organ excluding spleen and bone marrow with VP-16 60 mg/kg and Cytoxan 100 mg/kg. Patients underwent therapy on day -14 with VP-16 given on day -4, Cytoxan given on day -2 and PBSC infused on day +1.
Skin and subcutaneous tissue disorders Bruising (in absence of Grade 3 or 4 thrombocytopenia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Specify, __)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 12 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	24.3% 9/37 • Number of events 9 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Flushing	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	32.4% 12/37 • Number of events 12 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	40.5% 15/37 • Number of events 15 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	18.9% 7/37 • Number of events 7 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Immune system disorders Allergy/Immunology - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Ear and labyrinth disorders Hearing: patients without baseline audiogram and not enrolled in a monitoring program	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Investigations Failure to engraft	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Blood/Bone Marrow - Other (Specify, __)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	37.8% 14/37 • Number of events 15 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Bone marrow cellularity	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hemoglobin	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	100.0% 37/37 • Number of events 40 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Leukocytes (total WBC)	40.0% 2/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Leukocytes (total WBC) for BMT studies, if specified in the protocol.	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	97.3% 36/37 • Number of events 37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Lymphopenia	100.0% 5/5 • Number of events 10 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	100.0% 37/37 • Number of events 46 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	40.0% 2/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	35.1% 13/37 • Number of events 14 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	94.6% 35/37 • Number of events 35 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Platelets	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Platelets for BMT studies, if specified in the protocol.	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	100.0% 37/37 • Number of events 37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Transfusion: Platelets	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Transfusion: Platelets for BMT studies, if specified in the protocol.	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	86.5% 32/37 • Number of events 32 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Transfusion: pRBCs	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Transfusion: pRBCs for BMT studies, if specified in the protocol.	80.0% 4/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	81.1% 30/37 • Number of events 30 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Cardiac Arrhythmia - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Supraventricular and nodal arrhythmia	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	43.2% 16/37 • Number of events 20 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Cardiac General - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Hypertension	40.0% 2/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 10 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Hypotension	60.0% 3/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	59.5% 22/37 • Number of events 22 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Left ventricular systolic dysfunction	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 9 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Cardiac disorders Edema	60.0% 3/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 10 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Vascular disorders Prothrombin Time	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	0.00% 0/37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Vascular disorders INR (International Normalized Ratio of prothrombin time)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Vascular disorders PTT (Partial Thromboplastin Time)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Constitutional Symptoms - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Fatigue (asthenia, lethargy, malaise)	100.0% 5/5 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	94.6% 35/37 • Number of events 37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	29.7% 11/37 • Number of events 12 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Insomnia	80.0% 4/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	70.3% 26/37 • Number of events 28 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Rigors/chills	60.0% 3/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	56.8% 21/37 • Number of events 21 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Sweating (diaphoresis)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Weight gain	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Weight loss	40.0% 2/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	32.4% 12/37 • Number of events 12 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Extensive Skin Rash	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Pigmentation changes (e.g., vitiligo)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Pruritus/itching	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	43.2% 16/37 • Number of events 17 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Rash/dermatitis associated with high-dose chemotherapy or BMT studies.	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	43.2% 16/37 • Number of events 16 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Rash/desquamation	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Rash/desquamation associated with graft versus host disease (GVHD)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	21.6% 8/37 • Number of events 9 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Urticaria (hives, welts, wheals)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Skin and subcutaneous tissue disorders Wound complication, non-infectious	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection - Other (Specify, __)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Endocrine disorders Endocrine - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Endocrine disorders Hot flashes/flushes	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Anorexia	40.0% 2/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	70.3% 26/37 • Number of events 26 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Ascites (non-malignant)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Colitis	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Constipation	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 10 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Dehydration	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Diarrhea	60.0% 3/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	81.1% 30/37 • Number of events 32 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	29.7% 11/37 • Number of events 11 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	51.4% 19/37 • Number of events 19 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Flatulence	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Gastrointestinal - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Heartburn/dyspepsia	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	62.2% 23/37 • Number of events 23 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Nausea	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	97.3% 36/37 • Number of events 38 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Salivary gland changes/saliva	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	18.9% 7/37 • Number of events 7 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.	60.0% 3/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	100.0% 37/37 • Number of events 37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Taste alteration (dysgeusia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	35.1% 13/37 • Number of events 13 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Ulcer, GI	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Gastrointestinal disorders Vomiting	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	97.3% 36/37 • Number of events 37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hematemesis	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hematuria (in the absence of vaginal bleeding)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hemoptysis	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	32.4% 12/37 • Number of events 12 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Melena/GI bleeding	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Rectal bleeding/hematochezia	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hemorrhage, GU	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hemorrhage, pulmonary/upper respiratory	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 10 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Hemorrhage/Bleeding - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Blood and lymphatic system disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	21.6% 8/37 • Number of events 8 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Hepatobiliary disorders Hepatic enlargement	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Febrile neutropenia	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	81.1% 30/37 • Number of events 30 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection with unknown ANC	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Herpes Zoster (COH)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection with grade 3 or 4 neutropenia	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	24.3% 9/37 • Number of events 9 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection without neutropenia	60.0% 3/5 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 11 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection, Bacterial (COH)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection, Fungal (COH)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Infections and infestations Infection, Viral (COH)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	80.0% 4/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	73.0% 27/37 • Number of events 28 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	80.0% 4/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	64.9% 24/37 • Number of events 25 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	100.0% 37/37 • Number of events 37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Alkaline phosphatase	80.0% 4/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	21.6% 8/37 • Number of events 8 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Amylase	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Bicarbonate, serum-low	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	70.3% 26/37 • Number of events 26 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	40.0% 2/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	100.0% 5/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	97.3% 36/37 • Number of events 36 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Cholesterol, serum-high (hypercholesteremia)	80.0% 4/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	64.9% 24/37 • Number of events 24 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Creatinine	60.0% 3/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 10 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	100.0% 5/5 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	67.6% 25/37 • Number of events 25 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	24.3% 9/37 • Number of events 9 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	80.0% 4/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	59.5% 22/37 • Number of events 22 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	80.0% 4/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	75.7% 28/37 • Number of events 29 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	80.0% 4/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	89.2% 33/37 • Number of events 35 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	60.0% 3/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	78.4% 29/37 • Number of events 29 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 7 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Specify, __)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Ataxia (incoordination)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Confusion	60.0% 3/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	16.2% 6/37 • Number of events 6 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Dizziness	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	40.5% 15/37 • Number of events 15 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Hallucinations	20.0% 1/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	10.8% 4/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Mood alteration	80.0% 4/5 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	56.8% 21/37 • Number of events 33 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Neurology - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Neuropathy: motor	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Neuropathy: sensory	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	32.4% 12/37 • Number of events 13 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Somnolence/depressed level of consciousness	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	13.5% 5/37 • Number of events 5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Syncope (fainting)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Nervous system disorders Tremor	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Eye disorders Dry eye syndrome	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Eye disorders Ocular surface disease	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	0.00% 0/37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Eye disorders Ocular/Visual - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Eye disorders Ophthalmoplegia/diplopia (double vision)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Pain	100.0% 5/5 • Number of events 15 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	86.5% 32/37 • Number of events 88 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Pain - Other (Specify, __)	40.0% 2/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	62.2% 23/37 • Number of events 55 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia, Other (COH)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	0.00% 0/37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Cough	60.0% 3/5 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	56.8% 21/37 • Number of events 21 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	60.0% 3/5 • Number of events 4 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 10 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	37.8% 14/37 • Number of events 14 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	18.9% 7/37 • Number of events 7 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	8.1% 3/37 • Number of events 3 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	21.6% 8/37 • Number of events 9 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis (radiographic changes)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	0.00% 0/37 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Specify, __)	20.0% 1/5 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	27.0% 10/37 • Number of events 12 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Renal and urinary disorders Incontinence	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Renal and urinary disorders Renal/Genitourinary - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Renal and urinary disorders Urinary frequency/urgency	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Renal and urinary disorders Urine color change	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Investigations Secondary Malignancy - possibly related to cancer treatment (Specify, __)	40.0% 2/5 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	24.3% 9/37 • Number of events 13 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Reproductive system and breast disorders Irregular menses (change from baseline)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Reproductive system and breast disorders Libido	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
General disorders Syndromes - Other (Specify, __)	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	2.7% 1/37 • Number of events 1 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.
Vascular disorders Thrombosis/thrombus/embolism	0.00% 0/5 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.	5.4% 2/37 • Number of events 2 • Adverse Event and Vital Status data both were captured from the initial treatment to the off protocol, up to 5 years. Among the 54 enrolled patients, 12 patients had unfavorable bio-distribution on imaging dose. Those 12 patients didn't receive any study drug and had no toxicity data collected. Therefore, the adverse event data are based on the 42 patients, who had favorable bio-distribution on imaging dose and received the study treatment.

Additional Information

Dr. Auayporn Nademanee

City of Hope National Medical Center

Phone: 626-256-4673

Email: ANademanee@coh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place