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NCT00554788 · OUTCOME

Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma · Source last updated 2025-01-13

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 30 days after completion of study treatment

What was measured

Grade 3 and higher toxicities will be descriptively summarized.

Analysis population: Three ineligible patients were excluded from this analysis. Two patients who did not receive therapy were also excluded from this analysis.

Groups in this outcome

Stage 2/3 Patients

Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).

Stage 4a Patients

Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.

Stage 4b Patients

Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Stage 2/3 Patients18
Stage 4a Patients18
Stage 4b Patients19

Reported measurements

Abdominal pain
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Acute kidney injury
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients16.7Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Anemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Anorexia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients33.3Not reportedNot reportedNot reportedNot reported
Stage 4b Patients15.8Not reportedNot reportedNot reportedNot reported
Apnea
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Catheter related infection
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Dehydration
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4b Patients10.5Not reportedNot reportedNot reportedNot reported
Depressed level of consciousness
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients16.7Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Encephalopathy
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Enterocolitis
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Enterocolitis infectious
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Esophagitis
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients55.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients55.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients36.8Not reportedNot reportedNot reportedNot reported
Fever
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
GGT increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Gastric hemorrhage
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Hearing impaired
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Hypermagnesemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Hypertension
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Hypocalcemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients10.5Not reportedNot reportedNot reportedNot reported
Hypoglycemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients27.8Not reportedNot reportedNot reportedNot reported
Stage 4a Patients16.7Not reportedNot reportedNot reportedNot reported
Stage 4b Patients21.1Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients10.5Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients15.8Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients22.2Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients10.5Not reportedNot reportedNot reportedNot reported
Hypotension
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients2.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Infections and infestations - Other, specify
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients27.8Not reportedNot reportedNot reportedNot reported
Stage 4a Patients33.3Not reportedNot reportedNot reportedNot reported
Stage 4b Patients21.1Not reportedNot reportedNot reportedNot reported
Lower gastrointestinal hemorrhage
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Lung infection
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients16.7Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Mucositis oral
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients27.8Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Nausea
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients16.7Not reportedNot reportedNot reportedNot reported
Stage 4a Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Nervous system disorders - Other, specify
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients10.5Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Oral pain
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Pain
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Peripheral motor neuropathy
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Pharyngeal mucositis
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Pneumonitis
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Rectal pain
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Seizure
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Sepsis
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Sinus tachycardia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Sinusitis
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Skin infection
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients0Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Upper respiratory infection
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4b Patients0Not reportedNot reportedNot reportedNot reported
Vomiting
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients11.1Not reportedNot reportedNot reportedNot reported
Stage 4a Patients22.2Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
White blood cell decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients5.6Not reportedNot reportedNot reportedNot reported
Stage 4a Patients0Not reportedNot reportedNot reportedNot reported
Stage 4b Patients5.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5.6
      3. group Id
        OG002
        value
        0
    title
    Abdominal pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5.6
      3. group Id
        OG002
        value
        0
    title
    Acute kidney injury
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        16.7
      3. group Id
        OG002
        value
        5.3
    title
    Alanine aminotransferase increased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5.3
    title
    Anemia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11.1
      2. group Id
        OG001
        value
        33.3
      3. group Id
        OG002
        value
        15.8
    title
    Anorexia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5.3
    title
    Apnea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        11.1
      3. group Id
        OG002
        value
        5.3
    title
    Aspartate aminotransferase increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        11.1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Catheter related infection
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        11.1
      3. group Id
        OG002
        value
        10.5
    title
    Dehydration
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5.3
    title
    Depressed level of consciousness
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5.6
      2. group Id
        OG001
        value
        16.7
      3. group Id
        OG002
        value
        0
    title
    Diarrhea
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5.3
    title
    Encephalopathy
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      19
    units
    Participants
description
Grade 3 and higher toxicities will be descriptively summarized.
groups
  1. description
    Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
    id
    OG000
    title
    Stage 2/3 Patients
  2. description
    Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    id
    OG001
    title
    Stage 4a Patients
  3. description
    Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    id
    OG002
    title
    Stage 4b Patients
param Type
NUMBER
population Description
Three ineligible patients were excluded from this analysis. Two patients who did not receive therapy were also excluded from this analysis.
reporting Status
POSTED
time Frame
Up to 30 days after completion of study treatment
title
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
type
SECONDARY
unit Of Measure
percentage of participants

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