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NCT01511562 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma · Source last updated 2026-01-30

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
7 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. \> \> carmustine: Given IV \> * thiotepa: Given IV \> * stem cell transplant \> * G-CSF

21 / 5454 / 5411 / 54
Arm II

Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. \> * cytarabine: Given IV \> * etoposide: Given IV \> * G-CSF

33 / 5453 / 5415 / 54

Group identifiers: EG000: Arm I · EG001: Arm II

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      5
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Conduction disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    term
    Supraventricular tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Endocrine disorders - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Sudden death NOS

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      54
      num Events
      381
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      54
      num Events
      233
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      10
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      54
      num Events
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      54
      num Events
      17
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Cardiac disorders - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Chest pain - cardiac
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Paroxysmal atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
      num Events
      10
    term
    Sinus tachycardia
Complete source fields
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    54
    description
    Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. \> \> carmustine: Given IV \> * thiotepa: Given IV \> * stem cell transplant \> * G-CSF
    id
    EG000
    other Num Affected
    54
    other Num At Risk
    54
    serious Num Affected
    21
    serious Num At Risk
    54
    title
    Arm I
  2. deaths Num Affected
    15
    deaths Num At Risk
    54
    description
    Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. \> * cytarabine: Given IV \> * etoposide: Given IV \> * G-CSF
    id
    EG001
    other Num Affected
    53
    other Num At Risk
    54
    serious Num Affected
    33
    serious Num At Risk
    54
    title
    Arm II
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      54
      num Events
      381
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      54
      num Events
      233
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      10
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      54
      num Events
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      54
      num Events
      17
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Cardiac disorders - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Chest pain - cardiac
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Paroxysmal atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
      num Events
      10
    term
    Sinus tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      5
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Conduction disorder
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    term
    Supraventricular tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Endocrine disorders - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Sudden death NOS
time Frame
7 years

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