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NCT00520130 · ADVERSE EVENTS

Adverse events

Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System · Source last updated 2019-03-05

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
103 months and 22 days
Other-event reporting threshold
0%

One participant was enrolled and given induction chemotherapy but was never randomized to Arm TMS or AC. Subject had one AE (infection with normal ANC or Grade 1 or 2 neutrophils: Pharynx). Subject was taken off study for disease progression and died.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm

TMS Arm Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy

36 / 4443 / 448 / 44
B - Cyclosporine (AC) Arm

AC Arm Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease Cyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d

41 / 4542 / 4519 / 45

Group identifiers: EG000: A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm · EG001: B - Cyclosporine (AC) Arm

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
      num Events
      6
    term
    Adult Respiratory Distress Syndrome (ARDS)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Albumin, serum-low (hypoalbuminemia)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Alkaline phosphatase
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Arthritis (non-septic)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Ataxia (incoordination)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Bilirubin (hyperbilirubinemia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    CNS cerebrovascular ischemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Carbon monoxide diffusion capacity (DL(co))

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      44
      num Events
      75
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      45
      num Events
      45
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      44
      num Events
      73
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      45
      num Events
      50
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Acidosis (metabolic or respiratory)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adult Respiratory Distress Syndrome (ARDS)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      44
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      45
      num Events
      23
    term
    Albumin, serum-low (hypoalbuminemia)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
      num Events
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      45
      num Events
      9
    term
    Alkaline phosphatase
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      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
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Amylase
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      4
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Bicarbonate, serum-low
Complete source fields
description
One participant was enrolled and given induction chemotherapy but was never randomized to Arm TMS or AC. Subject had one AE (infection with normal ANC or Grade 1 or 2 neutrophils: Pharynx). Subject was taken off study for disease progression and died.
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    44
    description
    TMS Arm Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy
    id
    EG000
    other Num Affected
    43
    other Num At Risk
    44
    serious Num Affected
    36
    serious Num At Risk
    44
    title
    A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm
  2. deaths Num Affected
    19
    deaths Num At Risk
    45
    description
    AC Arm Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease Cyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d
    id
    EG001
    other Num Affected
    42
    other Num At Risk
    45
    serious Num Affected
    41
    serious Num At Risk
    45
    title
    B - Cyclosporine (AC) Arm
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      44
      num Events
      75
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      45
      num Events
      45
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      44
      num Events
      73
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      45
      num Events
      50
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Acidosis (metabolic or respiratory)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adult Respiratory Distress Syndrome (ARDS)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      44
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      45
      num Events
      23
    term
    Albumin, serum-low (hypoalbuminemia)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
      num Events
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      45
      num Events
      9
    term
    Alkaline phosphatase
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      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
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Amylase
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      4
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Bicarbonate, serum-low
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      44
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    AST, SGOT(serum glutamic oxaloacetic transaminase)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      45
      num Events
      6
    term
    Adult Respiratory Distress Syndrome (ARDS)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Albumin, serum-low (hypoalbuminemia)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Alkaline phosphatase
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Allergic reaction/hypersensitivity (including drug fever)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Arthritis (non-septic)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Ataxia (incoordination)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Bilirubin (hyperbilirubinemia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    CNS cerebrovascular ischemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      44
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Carbon monoxide diffusion capacity (DL(co))
time Frame
103 months and 22 days

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Preserved source evidence · Not medical advice