Trial Outcomes & Findings for Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients (NCT NCT03613727)

Last Updated: 2023-11-07

Results Overview

To determine the effect of parenteral vitamin C on non-relapse mortality (NRM) at one year following myeloablative allogeneic HCT. Non-relapse mortality is defined as defined as mortality from complications of HCT but not tumor relapse, is usually from graft versus host disease (GVHD), infection, or organ failure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)

Results posted on

2023-11-07

Participant Flow

6 participants were consented and enrolled, but were not eligible to start treatment

Participant milestones

Participant milestones
Measure	IV Vitamin C Followed by Oral Vitamin C All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Vitamin C Followed by Oral Vitamin C n=55 Participants All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Age, Customized 18 - 21 years	1 Participants n=5 Participants
Age, Customized 22 - 29 years	2 Participants n=5 Participants
Age, Customized 30 - 39 years	7 Participants n=5 Participants
Age, Customized 40 - 49 years	5 Participants n=5 Participants
Age, Customized 50 - 59 years	21 Participants n=5 Participants
Age, Customized 60 - 69 years	18 Participants n=5 Participants
Age, Customized 70 - 79 years	1 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)

Outcome measures

Outcome measures
Measure	IV Vitamin C Followed by Oral Vitamin C n=55 Participants All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
The Proportion of Patients That Experience Non-relapse Mortality (NRM)	5 Participants

SECONDARY outcome

Timeframe: 30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT)

To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment.

Outcome measures

Outcome measures
Measure	IV Vitamin C Followed by Oral Vitamin C n=55 Participants All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Time From Transplant to Engraftment	12 Number of Days to engraftment Interval 9.0 to 15.0

SECONDARY outcome

Timeframe: 0 - 180 days after myeloablative allogeneic HCT

Percentage of patients with a diagnosis of acute GVHD

Outcome measures

Outcome measures
Measure	IV Vitamin C Followed by Oral Vitamin C n=55 Participants All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)	33 percentage of participants

SECONDARY outcome

Timeframe: Within first 30 days of myeloablative allogeneic HCT

Population: No participants had adverse events related to Vitamin C therapy.

The number of participants who have adverse events related to Vitamin C therapy

Outcome measures

Outcome measures
Measure	IV Vitamin C Followed by Oral Vitamin C n=55 Participants All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Determine Related to Vitamin C Therapy Adverse Events (AEs) Reported Using Criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)	0 Participants

Adverse Events

IV Vitamin C Followed by Oral Vitamin C

Serious events: 40 serious events

Other events: 55 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	IV Vitamin C Followed by Oral Vitamin C n=55 participants at risk All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Cardiac disorders Sinus Tachycardia	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Eye disorders Optic Nerve Disorder	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Abdominal Pain	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Diarrhea	16.4% 9/55 • Number of events 9 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Nausea	5.5% 3/55 • Number of events 3 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Mucositis	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
General disorders Fatigue	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
General disorders Fever	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Hepatobiliary disorders Sinusoidal obstruction syndrome	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Catheter Related Infection	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Lung Infection	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Sepsis	10.9% 6/55 • Number of events 6 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Urinary Tract Infection	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Viremia	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Injury, poisoning and procedural complications Fracture	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Psychiatric disorders Suicidial Ideation	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Renal and urinary disorders Acute Kidney Injury	5.5% 3/55 • Number of events 3 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Renal and urinary disorders Creatinie Increased	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Respiratory, thoracic and mediastinal disorders Dyspnea	5.5% 3/55 • Number of events 3 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Respiratory, thoracic and mediastinal disorders Hypoxia	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Vascular disorders Hypotension	9.1% 5/55 • Number of events 5 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Vascular disorders Hypertension	9.1% 5/55 • Number of events 5 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded

Other adverse events

Other adverse events
Measure	IV Vitamin C Followed by Oral Vitamin C n=55 participants at risk All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day. Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Blood and lymphatic system disorders Febrile Neutropenia	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Cardiac disorders Heart Failure	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Cardiac disorders Sinus Tachycardia	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Cardiac disorders Ventricular Tachycardia	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Ear and labyrinth disorders Hearing Impaired	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Eye disorders Optic Nerve Disorder	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Eye disorders Vision Decreased	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Diarrhea	25.5% 14/55 • Number of events 17 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Nausea	9.1% 5/55 • Number of events 5 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Mucositis Oral	36.4% 20/55 • Number of events 20 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Gastrointestinal disorders Small Intestinal Mucositis	14.5% 8/55 • Number of events 8 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
General disorders Fatigue	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
General disorders fever	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Hepatobiliary disorders Sinusoidal Obstruction Syndrome	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Appendicitis	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Epstein-Barr Virus Infection Reactivation	16.4% 9/55 • Number of events 9 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Cytomegalovirus Infection Reactivation	25.5% 14/55 • Number of events 14 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Enterocolitis Infection Reactivation	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Fungemia	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Herpes Simplex Reactivation	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Lung Infection	9.1% 5/55 • Number of events 7 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Sepsis	20.0% 11/55 • Number of events 12 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Skin Infection	5.5% 3/55 • Number of events 3 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Urinary Tract Infection	12.7% 7/55 • Number of events 7 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Infections and infestations Viremia	5.5% 3/55 • Number of events 3 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Injury, poisoning and procedural complications Fracture	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Investigations Blood Bilirubin Increased	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Metabolism and nutrition disorders Anorexia	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Metabolism and nutrition disorders Hyperglycemia	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Metabolism and nutrition disorders Hypernatremia	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Metabolism and nutrition disorders Hypoglycemia	16.4% 9/55 • Number of events 10 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Metabolism and nutrition disorders Tumor Lysis Syndrome	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Musculoskeletal and connective tissue disorders Back Pain	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Nervous system disorders Headache	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Nervous system disorders Seizure	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Nervous system disorders Spinal Cord Compression	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Nervous system disorders Syncope	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Psychiatric disorders Depression	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Renal and urinary disorders Acute Kidney Injury	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Respiratory, thoracic and mediastinal disorders Dyspnea	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Respiratory, thoracic and mediastinal disorders Hypoxia	7.3% 4/55 • Number of events 4 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Vascular disorders Hypotension	9.1% 5/55 • Number of events 5 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Vascular disorders Hypertension	3.6% 2/55 • Number of events 2 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded
Psychiatric disorders Suicidial Ideation	1.8% 1/55 • Number of events 1 • Adverse Events were collected from Day 0 through Day 180. Adverse Events (AEs) \>/= grade 3 regardless of expectedness or attribution were recorded

Additional Information

BMT- CIT Team

Virginia Commonwealth University

Phone: 804-628-6430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place