Trial Outcomes & Findings for High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies (NCT NCT03146962)

NCT ID: NCT03146962

Last Updated: 2024-05-02

Results Overview

Number of patients with partial or complete pathological response in surgically resected tumor tissue: Pathological response rate is the number of patients with partial or complete pathological response in surgically resected tumor tissue. Pathologic response was assessed by tumor regression grade. This is a pathologic assessment of the amount of residual cancer cells in the specimen and the degree of fibrosis in the sample specimen. A completer response is 0% residual cancer cells. A partial response is 10-50% residual cancer cells, and no response is \>50% residual cancer cells within the tumor specimen.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

cohort A - 8 weeks

Results posted on

2024-05-02

Participant Flow

Participant milestones

Participant milestones
Measure
Cohort A: Vitamin C + Surgery
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort B: Vitamin C Only
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Overall Study
STARTED
7
21
3
3
4
3
3
7
3
7
Overall Study
COMPLETED
5
15
3
3
3
3
3
6
3
6
Overall Study
NOT COMPLETED
2
6
0
0
1
0
0
1
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort A: Vitamin C + Surgery
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort B: Vitamin C Only
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Overall Study
Lost to Follow-up
1
1
0
0
0
0
0
0
0
0
Overall Study
Adverse Event
0
3
0
0
0
0
0
1
0
0
Overall Study
Withdrawal by Subject
0
0
0
0
1
0
0
0
0
0
Overall Study
Death
0
1
0
0
0
0
0
0
0
0
Overall Study
COVID Precautions
1
0
0
0
0
0
0
0
0
0
Overall Study
Physician Decision
0
0
0
0
0
0
0
0
0
1
Overall Study
Started New Treatment
0
1
0
0
0
0
0
0
0
0

Baseline Characteristics

High Dose Vitamin C Intravenous Infusion in Patients With Resectable or Metastatic Solid Tumor Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort A: Vitamin C + Surgery
n=7 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort B: Vitamin C Only
n=21 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
n=3 Participants
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
n=3 Participants
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
n=4 Participants
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
n=3 Participants
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
n=3 Participants
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
n=7 Participants
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
n=3 Participants
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
n=7 Participants
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Total
n=61 Participants
Total of all reporting groups
Age, Continuous
49.02 years
n=5 Participants
60.72 years
n=7 Participants
54.51 years
n=5 Participants
55.5 years
n=4 Participants
75.66 years
n=21 Participants
48.46 years
n=10 Participants
77.73 years
n=115 Participants
58.05 years
n=24 Participants
69.92 years
n=42 Participants
58.94 years
n=42 Participants
61.66 years
n=42 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
14 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
0 Participants
n=10 Participants
2 Participants
n=115 Participants
3 Participants
n=24 Participants
1 Participants
n=42 Participants
2 Participants
n=42 Participants
31 Participants
n=42 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
7 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
3 Participants
n=10 Participants
1 Participants
n=115 Participants
4 Participants
n=24 Participants
2 Participants
n=42 Participants
5 Participants
n=42 Participants
30 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
4 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
10 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
16 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
2 Participants
n=10 Participants
3 Participants
n=115 Participants
7 Participants
n=24 Participants
2 Participants
n=42 Participants
7 Participants
n=42 Participants
50 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
4 Participants
n=42 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
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
2 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
6 Participants
n=42 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
14 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
2 Participants
n=21 Participants
3 Participants
n=10 Participants
3 Participants
n=115 Participants
5 Participants
n=24 Participants
2 Participants
n=42 Participants
5 Participants
n=42 Participants
44 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
6 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
7 Participants
n=42 Participants
Region of Enrollment
United States
7 participants
n=5 Participants
21 participants
n=7 Participants
3 participants
n=5 Participants
3 participants
n=4 Participants
4 participants
n=21 Participants
3 participants
n=10 Participants
3 participants
n=115 Participants
7 participants
n=24 Participants
3 participants
n=42 Participants
7 participants
n=42 Participants
61 participants
n=42 Participants

PRIMARY outcome

Timeframe: cohort A - 8 weeks

Population: Only the 6 patients who had surgery from Cohort A, and thus had evaluable tissue, were analyzed for this measure. Participants in Cohort B and C did not undergo surgery, and were thus not evaluable.

Number of patients with partial or complete pathological response in surgically resected tumor tissue: Pathological response rate is the number of patients with partial or complete pathological response in surgically resected tumor tissue. Pathologic response was assessed by tumor regression grade. This is a pathologic assessment of the amount of residual cancer cells in the specimen and the degree of fibrosis in the sample specimen. A completer response is 0% residual cancer cells. A partial response is 10-50% residual cancer cells, and no response is \>50% residual cancer cells within the tumor specimen.

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=6 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Pathologic Response Based on Tumor Regression Grading in Cohort A Patients
1 Participants

PRIMARY outcome

Timeframe: Cohort B - 3 months

Population: DCR was not collected for Cohort A or Cohort C. 5 participants from Cohort B were missing scans and were therefor unevaluable.

Percentage of patients with complete response, partial response, or stable disease as a result of their therapy at 3 months

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=16 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
3-month Disease Control Rate (DCR) Will be Evaluated Using RECIST v 1.1 in Cohort B Patients.
1 Participants

PRIMARY outcome

Timeframe: Cohort C - 16 weeks

Population: Only patients that received a dose of Vitamin C in Cohort C were considered evaluable. In Cohort C, 30 out of 32 participants who received vitamin C were evaluated across dose levels. Cohort A and B were not dose escalations, and therefore were not evaluated for maximum tolerated dose.

Maximal tolerated dose will be evaluated by assessment of dose limiting toxicities for multiple dose levels. Dose limiting toxicity will be defined as any grade 3-4 adverse event possibly, probably, or definitely attributed to vitamin C therapy in the 21 days of protocol therapy. In any group of 3 patients, if one patient experiences dose limiting toxicity, the group will be expanded by 3 additional patients (eg. 6 for that group). If, at any dose level, 2 or more patients experience a dose limiting toxicity, the maximal tolerated dose will be reached, and further dose escalation will not be pursued. The dose level may then be expanded up to 10 additional patients to confirm the safety and toxicity at that dose level.

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=30 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization
Vitamin C Weekly Infusion Dose
1.25 g/kg
Maximal Tolerated Dose of High Dose Vitamin C in Combination With Y90 Radioembolization
Vitamin C Infusion Dose the Day of Y-90 Radioembolization
1.25 g/kg

SECONDARY outcome

Timeframe: cohort B - up to 6 months

Population: Participants from Cohort A and Cohort C were not assessed for PFS. 5 participants were missing scans from Cohort B and were therefore unevaluable.

PFS is defined as the time from registration to cancer progression or death due to any cause for up to 6 months. Cancer progression is defined using the Response Evaluation Criteria in Solid Tumors v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=16 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Progression-free Survival (PFS)
36 days
Interval 14.0 to 151.0

SECONDARY outcome

Timeframe: cohort B - up to 6 months cohort C - 16 weeks

Population: For Cohort B, only 16/21 participants had complete sets of imaging scans and were therefore evaluable. Participants in Cohort A were not evaluated for ORR. In Cohort C Dose Level 3, one patient withdrew from the study early and therefore was unevaluable. For cohort C dose level 6, three patients did not have complete imaging to be evaluable. For Cohort C Dose Level one participant withdrew prior to treatment and one participant was missing scans, therefore they were not unevaluable.

Number of patients with a partial response or complete response based on RECIST 1.1 Criteria.

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=16 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
n=3 Participants
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
n=3 Participants
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
n=3 Participants
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
n=3 Participants
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
n=3 Participants
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
n=4 Participants
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
n=3 Participants
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
n=5 Participants
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Objective Response Rate (ORR)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 24 hours post-infusion

Population: Pharmacokinetics data was not assessed for Cohort A or Cohort C. PK samples for 5 participants from Cohort B were not obtained and therefore only 16/21 participants were evaluable.

The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the Tmax and t(1/2) in hours

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=16 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Time to Maximum Concentration and Half-life of Vitamin C (t1/2) in Hours in Cohort B
T(max)
2.28 hours
Standard Deviation 0.38
Time to Maximum Concentration and Half-life of Vitamin C (t1/2) in Hours in Cohort B
t(1/2)
6.46 hours
Standard Deviation 1.44

SECONDARY outcome

Timeframe: Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration.

Population: Overall number of participants analyzed includes any participants that were enrolled in the study and received at least one dose of Vitamin C.

The number of participants per cohort who experienced a Grade 3 or 4 adverse event (as defined by CTCAE v4.03) that was deemed possibly, probably, or definitely related to Vitamin C.

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=7 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
n=19 Participants
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
n=3 Participants
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
n=3 Participants
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
n=4 Participants
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
n=3 Participants
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
n=3 Participants
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
n=7 Participants
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
n=3 Participants
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
n=6 Participants
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Alkaline Phosphatase Increase
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Aspartate Aminotransferase Increase
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Alanine Aminotransferase Increase
0 Participants
3 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Anemia
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Hypokalemia
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Blood Bilirubin Increased
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Hypertension
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Fatigue
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Generalized Muscle Weakness
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Confusion
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Scrotal Pain
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Syncope
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Safety of High Dose Vitamin C Administration Using CTCAE 4.03.
Hemolysis
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 24 hours post-infusion

Population: Pharmacokinetics were not assessed for Cohort A and C. PK samples for 5 participants from Cohort B were not obtained and therefore only 16/21 participants were evaluable.

The serum concentration of vitamin C was serially measured following vitamin C infusion at 1.25 g/kg at various timepoints up to 24 hours post infusion to determine the maximum concentration (Cmax) in mM.

Outcome measures

Outcome measures
Measure
Cohort A: Vitamin C + Surgery
n=16 Participants
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Maximum Concentration of Vitamin C in Hours in Cohort B
41.19 mM
Standard Deviation 10.89

OTHER_PRE_SPECIFIED outcome

Timeframe: cohort A - 8 weeks, cohort B - up to 6 months

Molecular signature of vitamin C efficacy will be determined using RNA sequencing and compared between KRAS or BRAF mutant vs wild type tumors. Organoids will be prepared from resected tumor samples and treated with vitamin C.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: cohort A - 8 weeks, cohort B - up to 6 months, Cohort C - 16 weeks

To explore potential correlation of gene expression pattern with anti-tumor activity of vitamin C, we plan to perform RNA sequencing using surgical sample in cohort A patients who will receive vitamin C infusion pre-operatively.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: cohort A - 8 weeks, cohort B - up to 6 months, Cohort C - 16 weeks

Immunohistochemical (IHC) staining for GLUT1 protein expression will be performed on Formalin Fixed Paraffin Embedded (FFPE) tumor tissues. Immunohistochemical (IHC) staining for phosphor-AMPK will be performed on Formalin Fixed Paraffin Embedded (FFPE) tumor tissues to assess AMPK activation.

Outcome measures

Outcome data not reported

Adverse Events

Cohort A: Vitamin C + Surgery

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Cohort B Vitamin C Only

Serious events: 4 serious events
Other events: 18 other events
Deaths: 1 deaths

Cohort C: Vitamin C + Y-90 Dose Level 1

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort C: Vitamin C + Y-90 Dose Level 2

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort C: Vitamin C + Y-90 Dose Level 3

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort C: Vitamin C + Y-90 Dose Level 4

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort C: Vitamin C + Y-90 Dose Level 5

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Cohort C: Vitamin C + Y-90 Dose Level 6

Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths

Cohort C: Vitamin C + Y-90 Dose Level 7

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Cohort C: Vitamin C + Y-90 Dose Level 8

Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Cohort A: Vitamin C + Surgery
n=7 participants at risk
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort B Vitamin C Only
n=19 participants at risk
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
n=3 participants at risk
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
n=3 participants at risk
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
n=4 participants at risk
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
n=3 participants at risk
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
n=3 participants at risk
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
n=7 participants at risk
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
n=3 participants at risk
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
n=6 participants at risk
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Blood and lymphatic system disorders
Anemia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Psychiatric disorders
Confusion
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Abdominal Pain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Metabolism and nutrition disorders
Anorexia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Fever
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Injury, poisoning and procedural complications
Wound Infection
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Vomiting
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Reproductive system and breast disorders
Scrotal Pain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Cardiac disorders
Atrial Fibrillation
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Abdominal Distension
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Blood and lymphatic system disorders
Hemolysis
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Syncope
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.

Other adverse events

Other adverse events
Measure
Cohort A: Vitamin C + Surgery
n=7 participants at risk
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort B Vitamin C Only
n=19 participants at risk
Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for up to 6 months. Vitamin C: Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
Cohort C: Vitamin C + Y-90 Dose Level 1
n=3 participants at risk
Vitamin C will be administered at a dose of 0.5 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 2
n=3 participants at risk
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C.
Cohort C: Vitamin C + Y-90 Dose Level 3
n=4 participants at risk
Vitamin C will be administered at a dose of 0.75 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 4
n=3 participants at risk
Vitamin C will be administered at a dose of 1 g/kg intravenously for 4 days /week for 1-2 weeks prior to and following Y90 therapy for a total of 4 weeks of vitamin C. A single dose of Vitamin C at 0.5g/kg will also be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment.
Cohort C: Vitamin C + Y-90 Dose Level 5
n=3 participants at risk
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 6
n=7 participants at risk
A single dose of Vitamin C at 0.75g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 7
n=3 participants at risk
A single dose of Vitamin C at 1g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Cohort C: Vitamin C + Y-90 Dose Level 8
n=6 participants at risk
A single dose of Vitamin C at 1.25g/kg will be administered on the day of Y90 radioembolization, administered prior to or within 24 hours of a Y90 treatment. Vitamin C will also be administered at a dose of 1.25 g/kg intravenously for 4 days/week for 1-2 weeks following Y90 therapy.
Gastrointestinal disorders
Abdominal pain
28.6%
2/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
36.8%
7/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
57.1%
4/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Fatigue
28.6%
2/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
31.6%
6/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
57.1%
4/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
2/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Alkaline phosphatase increased
28.6%
2/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
26.3%
5/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
71.4%
5/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Alanine aminotransferase increased
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
21.1%
4/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
100.0%
7/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Blood bilirubin increased
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
42.9%
3/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Constipation
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
15.8%
3/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
2/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Vomiting
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
21.1%
4/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
42.9%
3/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
2/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Hypokalemia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
21.1%
4/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
50.0%
2/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
50.0%
3/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Aspartate aminotransferase increased
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
21.1%
4/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
100.0%
7/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Nausea
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
26.3%
5/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
28.6%
2/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Blood and lymphatic system disorders
Anemia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
57.1%
4/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
4/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Metabolism and nutrition disorders
Hypoalbuminemia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
2/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Fever
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Pain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
15.8%
3/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
28.6%
2/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Musculoskeletal and connective tissue disorders
Flank Pain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
42.1%
8/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
28.6%
2/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Headache
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Edema Limbs
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
2/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Reproductive system and breast disorders
Pelvic Pain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Neutrophil Count Decreased
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Gastrointestinal disorders Other, Bleeding Gums
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Seizure
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Vascular disorders
Hypertension
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
15.8%
3/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Cold Intolerance
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Respiratory, thoracic and mediastinal disorders
Other: COVID-19 Infection
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Peripheral Sensory Neuropathy
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
15.8%
3/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Flu Like Symptoms
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Other: Increased Lactate Dehydrogenase
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Anal Hemorrhage
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Other: Blood in Stool
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Other: Neuropathy, Type Unspecified
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Abdominal distension
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Activity Change
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Metabolism and nutrition disorders
Anorexia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
66.7%
2/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Psychiatric disorders
Anxiety
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Other: Bleeding Gums
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Bloating
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Chest Pain, unspecified
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Chills
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Metabolism and nutrition disorders
Dehydration
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Metabolism and nutrition disorders
Hypomagnesemia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Diaphoresis
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Diarrhea
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Dizziness
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Other: Dry Heaves
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Creatinine Increased
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Edema face
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Injury, poisoning and procedural complications
Fall
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: "Feeling Shaky"
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Flatulence
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Skin and subcutaneous tissue disorders
Other: Folliculitis
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Metabolism and nutrition disorders
Hypocalcemia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Musculoskeletal and connective tissue disorders
Neck Pain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
10.5%
2/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Weight Loss
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Cardiac disorders
Other: Chest tightness/discomfort
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Musculoskeletal and connective tissue disorders
Back Pain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
75.0%
3/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Cardiac disorders
Other: Tachycardia, unspecified
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Gastrointestinal disorders
Ascites
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Renal and urinary disorders
Urinary Frequency
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Musculoskeletal and connective tissue disorders
Other: Loss of Hand Movement
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Platelet Count Decreased
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Lymphocyte Count Decreased
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Psychiatric disorders
Insomnia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
42.9%
3/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Skin and subcutaneous tissue disorders
Periorbital edema
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
25.0%
1/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Syncope
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Skin and subcutaneous tissue disorders
Other: Rash (Unspecified)
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
16.7%
1/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Weight gain
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Nervous system disorders
Somnolence
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Hepatobiliary disorders
Portal Vein Thrombosis
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Vascular disorders
Hypotension
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Night Sweats
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Increased Thirst
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Appetite Change
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
14.3%
1/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
General disorders
Other: Jaundice
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Investigations
Other: Ketosis
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
5.3%
1/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/19 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/4 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
33.3%
1/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/7 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/3 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.
0.00%
0/6 • Adverse events were assessed from the start of study treatment to 30 days after the last infusion of vitamin C. For Cohort A and C, this was approximately 2 months. For Cohort B this was about a 6 month duration. Some study participants were enrolled in the trial, but did not receive study treatment, so they are not included in the at risk population.
All enrolled participants were assessed for death. Only participants treated were assessed for adverse events. Two participants that were enrolled in Cohort B Vitamin C Only were withdrawn prior to receiving study treatment. One participant that was enrolled in Vitamin C + Y-90: Dose Level 8 was withdrawn from the study before receiving study treatment. Therefore they were not included in the at risk population for adverse events, only mortality.

Additional Information

Dr. Manish Shah, Sponsor-Investigator

Weill Cornell Medicine

Phone: 646-962-6200

Results disclosure agreements

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