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NCT00945724 · ADVERSE EVENTS

Adverse events

Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis · Source last updated 2025-05-30

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
All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
Other-event reporting threshold
5%

SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Safety Population

All patients who have received at least one dose of treatment will be considered as Safety Population

19 / 5447 / 5412 / 54
R-CHOP + Lyposomal Cytarabine

Subjects treated with R-CHOP (CHOP21).

17 / 5447 / 540 / 54
HD-MTX

Subjects treated with HD-MTX.

3 / 4817 / 480 / 48

Group identifiers: EG000: Safety Population · EG001: R-CHOP + Lyposomal Cytarabine · EG002: HD-MTX

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
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Increase of neutrophilis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Prostatic Cancer
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Thrombosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Cardiac general pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Syncope
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    CNS cerebrovascular ischemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Neuropathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Intracranial hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Febrile neutropenia

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Alopecia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
      num Events
      13
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
      num Events
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      48
      num Events
      3
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      54
      num Events
      19
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      54
      num Events
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      48
      num Events
      3
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      54
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Diarreha
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      54
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Erythema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
      num Events
      20
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      48
      num Events
      4
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      54
      num Events
      17
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Flue-like Syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      54
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      54
      num Events
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
      num Events
      21
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      54
      num Events
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Leukopenia
Complete source fields
description
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    54
    description
    All patients who have received at least one dose of treatment will be considered as Safety Population
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    54
    serious Num Affected
    19
    serious Num At Risk
    54
    title
    Safety Population
  2. deaths Num Affected
    0
    deaths Num At Risk
    54
    description
    Subjects treated with R-CHOP (CHOP21).
    id
    EG001
    other Num Affected
    47
    other Num At Risk
    54
    serious Num Affected
    17
    serious Num At Risk
    54
    title
    R-CHOP + Lyposomal Cytarabine
  3. deaths Num Affected
    0
    deaths Num At Risk
    48
    description
    Subjects treated with HD-MTX.
    id
    EG002
    other Num Affected
    17
    other Num At Risk
    48
    serious Num Affected
    3
    serious Num At Risk
    48
    title
    HD-MTX
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Alopecia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
      num Events
      13
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
      num Events
      10
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      48
      num Events
      3
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      54
      num Events
      19
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      54
      num Events
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      48
      num Events
      3
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      54
      num Events
      9
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Diarreha
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      54
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Erythema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
      num Events
      20
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
      num Events
      16
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      48
      num Events
      4
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      54
      num Events
      17
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Flue-like Syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      54
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      54
      num Events
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
      num Events
      21
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      54
      num Events
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Leukopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Increase of neutrophilis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Prostatic Cancer
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Thrombosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Cardiac general pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Syncope
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    CNS cerebrovascular ischemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Neuropathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 5.1
    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
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Intracranial hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 5.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      48
      num Events
      0
    term
    Febrile neutropenia
time Frame
All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group

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