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NCT00059839 · ADVERSE EVENTS

Adverse events

Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma · Source last updated 2014-09-22

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

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

Collection time frame
Not reported
Other-event reporting threshold
0%

64 patients are included for Arm I adverse events as one patient was deemed ineligible. 61 patients are included for Arm II adverse events as three patients were deemed ineligible.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Standard (APO) With Vincristine (Arm I)

In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.

2 / 6447 / 64Not reported / Not reported
Consolidation (Includes Vinblastine) (Arm II)

In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.

4 / 6152 / 61Not reported / Not reported

Group identifiers: EG000: Standard (APO) With Vincristine (Arm I) · EG001: Consolidation (Includes Vinblastine) (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. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    "Blood and lymphatic system disorders - Other"
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Febrile neutropenia
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Cardiac arrest
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    "Cardiac disorders - Other"
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Vomiting
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Death NOS
  9. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Hepatic failure
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Activated partial thromboplastin time prolonged
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Aspartate aminotransferase increased
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    CPK increased

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      64
      num Events
      14
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      61
      num Events
      24
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      64
      num Events
      7
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      61
      num Events
      18
    term
    Febrile neutropenia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      64
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    "Cardiac disorders - Other"
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Conduction disorder
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    Sinus tachycardia
  7. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Middle ear inflammation
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Blurred vision
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Cataract
  10. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    "Eye disorders - Other"
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      64
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      5
    term
    Abdominal pain
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Anal mucositis
Complete source fields
description
64 patients are included for Arm I adverse events as one patient was deemed ineligible. 61 patients are included for Arm II adverse events as three patients were deemed ineligible.
event Groups
  1. description
    In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    64
    serious Num Affected
    2
    serious Num At Risk
    64
    title
    Standard (APO) With Vincristine (Arm I)
  2. description
    In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    61
    serious Num Affected
    4
    serious Num At Risk
    61
    title
    Consolidation (Includes Vinblastine) (Arm II)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      64
      num Events
      14
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      61
      num Events
      24
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Disseminated intravascular coagulation
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      64
      num Events
      7
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      61
      num Events
      18
    term
    Febrile neutropenia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      64
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    "Cardiac disorders - Other"
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Conduction disorder
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    term
    Sinus tachycardia
  7. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Middle ear inflammation
  8. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Blurred vision
  9. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Cataract
  10. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    "Eye disorders - Other"
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      64
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      61
      num Events
      5
    term
    Abdominal pain
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Anal mucositis
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    "Blood and lymphatic system disorders - Other"
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Febrile neutropenia
  5. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    Cardiac arrest
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    "Cardiac disorders - Other"
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Vomiting
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      64
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Death NOS
  9. organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Hepatic failure
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Activated partial thromboplastin time prolonged
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    term
    Aspartate aminotransferase increased
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      64
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    term
    CPK increased

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice