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NCT01962103 · ADVERSE EVENTS

Adverse events

Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors · Source last updated 2019-12-27

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
Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively. Median treatment duration in Phase 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), rhabdomyosarcoma = 5 weeks (1-13).
Other-event reporting threshold
5%

All participants in both portions of the study were followed for 28 days after discontinuing treatment for safety and monitoring of AEs. AE's were analyzed in terms of TEAEs, which were defined as any AEs that began or worsened in severity on or after the start of study drug through 28 days after the last dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Nab-Paclitaxel 120 mg/m^2

nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).

10 / 1616 / 1614 / 16
Phase 1: Nab-Paclitaxel 150 mg/m^2

nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

7 / 88 / 87 / 8
Phase 1: Nab-Paclitaxel 180 mg/m^2

nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

6 / 1414 / 1411 / 14
Phase 1: Nab-Paclitaxel 210 mg/m^2

nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

5 / 1111 / 115 / 11
Phase 1: Nab-Paclitaxel 240 mg/m^2

nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

3 / 88 / 88 / 8
Phase 1: Nab-Paclitaxel 270 mg/m^2

nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.

4 / 77 / 75 / 7
Phase 2: Nab-Paclitaxel 240 mg/m^2

Participants with Ewing's sarcoma, neuroblastoma, or rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.

23 / 4242 / 4225 / 42

Group identifiers: EG000: Phase 1: Nab-Paclitaxel 120 mg/m^2 · EG001: Phase 1: Nab-Paclitaxel 150 mg/m^2 · EG002: Phase 1: Nab-Paclitaxel 180 mg/m^2 · EG003: Phase 1: Nab-Paclitaxel 210 mg/m^2 · EG004: Phase 1: Nab-Paclitaxel 240 mg/m^2 · EG005: Phase 1: Nab-Paclitaxel 270 mg/m^2 · EG006: Phase 2: Nab-Paclitaxel 240 mg/m^2

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Generalised oedema

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      27
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      18
      num At Risk
      42
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Lymphadenitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      42
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      23
      num At Risk
      42
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Neutrophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      42
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Thrombocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Aortic valve disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Pericardial effusion
Complete source fields
description
All participants in both portions of the study were followed for 28 days after discontinuing treatment for safety and monitoring of AEs. AE's were analyzed in terms of TEAEs, which were defined as any AEs that began or worsened in severity on or after the start of study drug through 28 days after the last dose of study drug.
event Groups
  1. deaths Num Affected
    14
    deaths Num At Risk
    16
    description
    nab-paclitaxel 120 mg/m\^2 intravenously (IV) on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the recommended phase 2 dose (RP2D).
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    10
    serious Num At Risk
    16
    title
    Phase 1: Nab-Paclitaxel 120 mg/m^2
  2. deaths Num Affected
    7
    deaths Num At Risk
    8
    description
    nab-paclitaxel 150 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    7
    serious Num At Risk
    8
    title
    Phase 1: Nab-Paclitaxel 150 mg/m^2
  3. deaths Num Affected
    11
    deaths Num At Risk
    14
    description
    nab-paclitaxel 180 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    6
    serious Num At Risk
    14
    title
    Phase 1: Nab-Paclitaxel 180 mg/m^2
  4. deaths Num Affected
    5
    deaths Num At Risk
    11
    description
    nab-paclitaxel 210 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    EG003
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Phase 1: Nab-Paclitaxel 210 mg/m^2
  5. deaths Num Affected
    8
    deaths Num At Risk
    8
    description
    nab-paclitaxel 240 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    EG004
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Phase 1: Nab-Paclitaxel 240 mg/m^2
  6. deaths Num Affected
    5
    deaths Num At Risk
    7
    description
    nab-paclitaxel 270 mg/m\^2 IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity to establish the RP2D.
    id
    EG005
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Phase 1: Nab-Paclitaxel 270 mg/m^2
  7. deaths Num Affected
    25
    deaths Num At Risk
    42
    description
    Participants with Ewing's sarcoma, neuroblastoma, or rhabdomyosarcoma: nab-paclitaxel at the RP2D (240 mg/m\^2 in participants weighing \> 10 kg and 11.5 mg/kg in participants weighing ≤ 10 kg) IV on Days 1, 8 and 15 of a 28-day cycle until disease progression, death, withdrawal of consent, or unacceptable toxicity.
    id
    EG006
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    23
    serious Num At Risk
    42
    title
    Phase 2: Nab-Paclitaxel 240 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      27
      num At Risk
      42
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      18
      num At Risk
      42
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Lymphadenitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      42
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      23
      num At Risk
      42
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Neutrophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      42
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Thrombocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Aortic valve disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Pericardial effusion
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      8
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
    term
    Generalised oedema
time Frame
Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively. Median treatment duration in Phase 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), rhabdomyosarcoma = 5 weeks (1-13).

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