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NCT00281879 · ADVERSE EVENTS

Adverse events

Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer · Source last updated 2017-09-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)

On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.

101 / 12819 / 128Not reported / Not reported
Busulfan and Cyclophosphamide (Cytoxan)

On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).

25 / 360 / 36Not reported / Not reported
BEAM Regimen

On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).

17 / 202 / 20Not reported / Not reported
Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)

A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.

0 / 00 / 0Not reported / Not reported
Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)

On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.

5 / 60 / 6Not reported / Not reported
ATG For Cord Blood Transplants

If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.

6 / 90 / 9Not reported / Not reported
DLI (Donor Leukocyte Infusion)

Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.

0 / 00 / 0Not reported / Not reported
Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)

On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.

1 / 10 / 1Not reported / Not reported

Group identifiers: EG000: Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI) · EG001: Busulfan and Cyclophosphamide (Cytoxan) · EG002: BEAM Regimen · EG003: Low-Dose Fludarabine and TBI(for Second Stem Cell Donation) · EG004: Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only) · EG005: ATG For Cord Blood Transplants · EG006: DLI (Donor Leukocyte Infusion) · EG007: Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Staph Sepsis
  2. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Altered mental status
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Pneumonia
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypoxia
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Death
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Fever
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Graft versus host disease (GVHD)
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      1
    term
    Acute Respiratory Distress Syndrome (ARDS)
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac Problems
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhea
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Orthostatic Hypertension

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Headache
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Nausea
Complete source fields
event Groups
  1. description
    On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    128
    serious Num Affected
    101
    serious Num At Risk
    128
    title
    Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)
  2. description
    On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    36
    serious Num Affected
    25
    serious Num At Risk
    36
    title
    Busulfan and Cyclophosphamide (Cytoxan)
  3. description
    On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    20
    serious Num Affected
    17
    serious Num At Risk
    20
    title
    BEAM Regimen
  4. description
    A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)
  5. description
    On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)
  6. description
    If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    9
    serious Num Affected
    6
    serious Num At Risk
    9
    title
    ATG For Cord Blood Transplants
  7. description
    Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
    id
    EG006
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    DLI (Donor Leukocyte Infusion)
  8. description
    On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
frequency Threshold
5
other Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Headache
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Nausea
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Staph Sepsis
  2. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Altered mental status
  3. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Pneumonia
  4. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypoxia
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Death
  6. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Fever
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Graft versus host disease (GVHD)
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      1
    term
    Acute Respiratory Distress Syndrome (ARDS)
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac Problems
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhea
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      128
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      0
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Orthostatic Hypertension

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Preserved source evidence · Not medical advice