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NCT00074490 · ADVERSE EVENTS

Adverse events

Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers · Source last updated 2018-12-31

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
Date treatment consent signed to date off study, approximately 5 years.
Other-event reporting threshold
0%

Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm IVD Cohort 1 (Th2 DLI)

Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).

1 / 11 / 10 / 1
Arm IVD Cohort 3 (Multiple Th2 DLI)

Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).

22 / 3428 / 3414 / 34
Arm IVA (12-day Expanded Th2 DLI)

Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.

37 / 4040 / 4022 / 40
Arm IVB (6-day Expanded Th2 DLI)

Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.

35 / 4438 / 4424 / 44
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)

Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.

31 / 4536 / 4522 / 45

Group identifiers: EG000: Arm IVD Cohort 1 (Th2 DLI) · EG001: Arm IVD Cohort 3 (Multiple Th2 DLI) · EG002: Arm IVA (12-day Expanded Th2 DLI) · EG003: Arm IVB (6-day Expanded Th2 DLI) · EG004: Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      34
      num Events
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      40
      num Events
      6
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      44
      num Events
      25
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      45
      num Events
      18
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      40
      num Events
      10
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      44
      num Events
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Acute vascular leak syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Adult Respiratory Distress Syndrome (ARDS)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Albumin, serum-low (hypoalbuminemia)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Alkaline phosphatase
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Alkalosis (metabolic or respiratory)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Amylase
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Apnea

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      34
      num Events
      38
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      40
      num Events
      53
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      44
      num Events
      81
    5. group Id
      EG004
      num Affected
      36
      num At Risk
      45
      num Events
      78
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      34
      num Events
      17
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      40
      num Events
      43
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      44
      num Events
      27
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      45
      num Events
      57
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      34
      num Events
      10
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      40
      num Events
      26
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      44
      num Events
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      45
      num Events
      13
    term
    Albumin, serum-low (hypoalbuminemia)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      40
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Alkaline phosphatase
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Alkalosis (metabolic or respiratory)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Amylase
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      40
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Arthritis (non-septic)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Ascites (non-malignant)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      34
      num Events
      15
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      40
      num Events
      13
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      44
      num Events
      24
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      45
      num Events
      35
    term
    Bilirubin (hyperbilirubinemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    CPK (creatine phosphokinase)
Complete source fields
description
Enrollment was 442 (221 donors; 221 patients). No data was collected from the donor population. 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive).
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Arm IVD Cohort 1 (Th2 DLI)
  2. deaths Num Affected
    14
    deaths Num At Risk
    34
    description
    Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).
    id
    EG001
    other Num Affected
    28
    other Num At Risk
    34
    serious Num Affected
    22
    serious Num At Risk
    34
    title
    Arm IVD Cohort 3 (Multiple Th2 DLI)
  3. deaths Num Affected
    22
    deaths Num At Risk
    40
    description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    EG002
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    37
    serious Num At Risk
    40
    title
    Arm IVA (12-day Expanded Th2 DLI)
  4. deaths Num Affected
    24
    deaths Num At Risk
    44
    description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    EG003
    other Num Affected
    38
    other Num At Risk
    44
    serious Num Affected
    35
    serious Num At Risk
    44
    title
    Arm IVB (6-day Expanded Th2 DLI)
  5. deaths Num Affected
    22
    deaths Num At Risk
    45
    description
    Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.
    id
    EG004
    other Num Affected
    36
    other Num At Risk
    45
    serious Num Affected
    31
    serious Num At Risk
    45
    title
    Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      34
      num Events
      38
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      40
      num Events
      53
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      44
      num Events
      81
    5. group Id
      EG004
      num Affected
      36
      num At Risk
      45
      num Events
      78
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      34
      num Events
      17
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      40
      num Events
      43
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      44
      num Events
      27
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      45
      num Events
      57
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      34
      num Events
      10
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      40
      num Events
      26
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      44
      num Events
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      45
      num Events
      13
    term
    Albumin, serum-low (hypoalbuminemia)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      34
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      40
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Alkaline phosphatase
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Alkalosis (metabolic or respiratory)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Amylase
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Anorexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      40
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Arthritis (non-septic)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Ascites (non-malignant)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      34
      num Events
      15
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      40
      num Events
      13
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      44
      num Events
      24
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      45
      num Events
      35
    term
    Bilirubin (hyperbilirubinemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    CPK (creatine phosphokinase)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      34
      num Events
      10
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      40
      num Events
      6
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      44
      num Events
      25
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      45
      num Events
      18
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      40
      num Events
      10
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      44
      num Events
      16
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Acidosis (metabolic or respiratory)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Acute vascular leak syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Adult Respiratory Distress Syndrome (ARDS)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Albumin, serum-low (hypoalbuminemia)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Alkaline phosphatase
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Alkalosis (metabolic or respiratory)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      44
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Amylase
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      34
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      44
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      34
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      44
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Apnea
time Frame
Date treatment consent signed to date off study, approximately 5 years.

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