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NCT02180867 · ADVERSE EVENTS

Adverse events

Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery · Source last updated 2026-06-17

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
Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose-Finding Level 1 CR

Dose-Finding Level 1 CR: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

6 / 94 / 91 / 9
Dose-Finding Level 1 RT

Dose-Finding Level 1 RT: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2

6 / 92 / 94 / 9
Dose-Finding Level 2 RT

Dose-Finding Level 2 RT: Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2

2 / 105 / 103 / 10
Regimen A

Regimen A: Chemoradiation plus pazopanib

33 / 4620 / 465 / 46
Regimen B

Regimen B: Chemoradiation alone

8 / 4310 / 439 / 43
Regimen C

Regimen C: Radiation therapy plus pazopanib

1 / 61 / 60 / 6
Regimen D

Regimen D: Radiation therapy alone

0 / 60 / 62 / 6

Group identifiers: EG000: Dose-Finding Level 1 CR · EG001: Dose-Finding Level 1 RT · EG002: Dose-Finding Level 2 RT · EG003: Regimen A · EG004: Regimen B · EG005: Regimen C · EG006: Regimen D

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
    notes
    Pediatric
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Creatinine increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Dehydration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    General disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hallucinations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hyperkalemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hypoxia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Ileus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Mucositis oral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    General disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    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
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Cardiac disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Vascular disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Lymphocyte count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Radiation recall reaction (dermatologic)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Wound dehiscence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Wound complication
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    General disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Localized edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adult
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Alanine aminotransferase increased
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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    9
    description
    Dose-Finding Level 1 CR: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    9
    serious Num Affected
    6
    serious Num At Risk
    9
    title
    Dose-Finding Level 1 CR
  2. deaths Num Affected
    4
    deaths Num At Risk
    9
    description
    Dose-Finding Level 1 RT: Adult: Pazopanib 600 mg; Pediatric: Pazopanib 350 mg/m2
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    9
    serious Num Affected
    6
    serious Num At Risk
    9
    title
    Dose-Finding Level 1 RT
  3. deaths Num Affected
    3
    deaths Num At Risk
    10
    description
    Dose-Finding Level 2 RT: Adult: Pazopanib 800 mg; Pediatric: Pazopanib 450 mg/m2
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Dose-Finding Level 2 RT
  4. deaths Num Affected
    5
    deaths Num At Risk
    46
    description
    Regimen A: Chemoradiation plus pazopanib
    id
    EG003
    other Num Affected
    20
    other Num At Risk
    46
    serious Num Affected
    33
    serious Num At Risk
    46
    title
    Regimen A
  5. deaths Num Affected
    9
    deaths Num At Risk
    43
    description
    Regimen B: Chemoradiation alone
    id
    EG004
    other Num Affected
    10
    other Num At Risk
    43
    serious Num Affected
    8
    serious Num At Risk
    43
    title
    Regimen B
  6. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Regimen C: Radiation therapy plus pazopanib
    id
    EG005
    other Num Affected
    1
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Regimen C
  7. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Regimen D: Radiation therapy alone
    id
    EG006
    other Num Affected
    0
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Regimen D
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Cardiac disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Vascular disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Lymphocyte count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Platelet count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Radiation recall reaction (dermatologic)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Wound dehiscence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Wound complication
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    General disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Localized edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Adult
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      30
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      25
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    term
    Alanine aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Investigations
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Creatinine increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Dehydration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    General disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hallucinations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hyperkalemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Hypoxia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Ileus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Mucositis oral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pediatric
    organ System
    General disorders
    source Vocabulary
    CTCv5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    term
    Pain
time Frame
Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year

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