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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01502 | Other Identifier | NCI CTRP |
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This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
Vitamin C is a nutritional supplement that can help fight inflammation. Most patients who have a stem cell transplant have lower than normal levels of vitamin C in their blood. Patients will receive intravenous Vitamin C the day after transplant for two weeks, followed by oral vitamin C until six months after transplant. The effect of the Vitamin C on non-relapse mortality (NRM), time to engraftment, rate of acute graft-versus-host disease and to characterize the safety and tolerability of the vitamin C regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Vitamin C followed by oral Vitamin C | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous (IV) and oral Vitamin C | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients That Experience Non-relapse Mortality (NRM) | 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. | 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Transplant to Engraftment | To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment. | 30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT) |
| To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD) |
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Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible to participate in the study:
Any of the following hematological malignancies:
Candidate for hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible.
human leukocyte antigen (HLA) matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched)
Stem cell graft from either bone marrow or peripheral blood
Negative serology for HIV
Age ≥ 18 to < 78 years of age
Karnofsky Performance Status of 70-100%
Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (BMT) Program guidelines
Ability to understand and the willingness to sign a written informed consent document. Note: The consent form must be signed and dated prior to initiation of stem cell transplant (SCT) preparative treatments.
Exclusion Criteria:
A patient who meets any of the following exclusion criteria is ineligible to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| William B Clark, MD | Massey Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/ Massey Cancer Center | Richmond | Virginia | 23298 | United States |
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6 participants were consented and enrolled, but were not eligible to start treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Patients That Experience Non-relapse Mortality (NRM) | 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. | Posted | Count of Participants | Participants | 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT) |
|
Adverse Events were collected from Day 0 through Day 180.
Adverse Events (AEs) >/= grade 3 regardless of expectedness or attribution were recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Tachycardia | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMT- CIT Team | Virginia Commonwealth University | 804-628-6430 | masseybmt@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2022 | Sep 28, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2019 | Jan 12, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007951 | Leukemia, Myeloid |
| D007948 | Leukemia, Monocytic, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
Percentage of patients with a diagnosis of acute GVHD |
| 0 - 180 days after myeloablative allogeneic HCT |
| 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) | The number of participants who have adverse events related to Vitamin C therapy | Within first 30 days of myeloablative allogeneic HCT |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time From Transplant to Engraftment | To determine the effect of the vitamin C regimen on the time to hematopoietic engraftment. | Posted | Median | Full Range | Number of Days to engraftment | 30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT) |
|
|
|
| Secondary | To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD) | Percentage of patients with a diagnosis of acute GVHD | Posted | Number | percentage of participants | 0 - 180 days after myeloablative allogeneic HCT |
|
|
|
| Secondary | 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) | The number of participants who have adverse events related to Vitamin C therapy | No participants had adverse events related to Vitamin C therapy. | Posted | Count of Participants | Participants | Within first 30 days of myeloablative allogeneic HCT |
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|
|
| 23 |
| 55 |
| 40 |
| 55 |
| 55 |
| 55 |
| Optic Nerve Disorder | Eye disorders | CTCAE v5.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v5.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE v5.0 | Systematic Assessment |
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| Sinusoidal obstruction syndrome | Hepatobiliary disorders | CTCAE v5.0 | Systematic Assessment |
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| Catheter Related Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Lung Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Viremia | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAE v5.0 | Systematic Assessment |
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| Suicidial Ideation | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
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| Creatinie Increased | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
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| Heart Failure | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
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| Hearing Impaired | Ear and labyrinth disorders | CTCAE v5.0 | Systematic Assessment |
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| Optic Nerve Disorder | Eye disorders | CTCAE v5.0 | Systematic Assessment |
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| Vision Decreased | Eye disorders | CTCAE v5.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Mucositis Oral | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Small Intestinal Mucositis | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v5.0 | Systematic Assessment |
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| fever | General disorders | CTCAE v5.0 | Systematic Assessment |
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| Sinusoidal Obstruction Syndrome | Hepatobiliary disorders | CTCAE v5.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Epstein-Barr Virus Infection Reactivation | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Cytomegalovirus Infection Reactivation | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Enterocolitis Infection Reactivation | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Fungemia | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Herpes Simplex Reactivation | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Lung Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Skin Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Viremia | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAE v5.0 | Systematic Assessment |
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| Blood Bilirubin Increased | Investigations | CTCAE v5.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
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| Tumor Lysis Syndrome | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
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| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
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| Muscle Weakness Lower Limb | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
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| Spinal Cord Compression | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Suicidial Ideation | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015470 | Leukemia, Myeloid, Acute |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |