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NCT01979536 · ADVERSE EVENTS

Adverse events

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma · Source last updated 2024-04-30

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
Enrollment up to 5 years after enrollment
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm BV (Brentuximab Vedotin, Combination Chemotherapy)

COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV

24 / 6857 / 683 / 68
Arm CZ (Crizotinib, Combination Chemotherapy)

COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV

41 / 6855 / 683 / 68

Group identifiers: EG000: Arm BV (Brentuximab Vedotin, Combination Chemotherapy) · EG001: Arm CZ (Crizotinib, Combination Chemotherapy)

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      68
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Esophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Ileus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      68
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      68
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Oral pain

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
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      68
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      68
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Periorbital edema
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      68
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
    term
    Dental caries
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      68
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Enterocolitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      68
    term
    Mucositis oral
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    68
    description
    COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
    id
    EG000
    other Num Affected
    57
    other Num At Risk
    68
    serious Num Affected
    24
    serious Num At Risk
    68
    title
    Arm BV (Brentuximab Vedotin, Combination Chemotherapy)
  2. deaths Num Affected
    3
    deaths Num At Risk
    68
    description
    COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    68
    serious Num Affected
    41
    serious Num At Risk
    68
    title
    Arm CZ (Crizotinib, Combination Chemotherapy)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      68
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      68
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Periorbital edema
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      68
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
    term
    Dental caries
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      68
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      68
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Enterocolitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Ileus
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      68
    term
    Mucositis oral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      68
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Esophagitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Ileus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      68
    term
    Mucositis oral
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      68
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      68
    term
    Oral pain
time Frame
Enrollment up to 5 years after enrollment

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Preserved source evidence · Not medical advice