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NCT01956669 · ADVERSE EVENTS

Adverse events

Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors · Source last updated 2020-08-12

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
Adverse Events were collected from first dose of study treatment plus 30 days post treatment, up to a maximum duration of 889 days.
Other-event reporting threshold
5%

Any sign and symptom that occurs during the study treatment plus the 30 days post-treatment. Maximum exposure to study treatments = 889 days (cohort 1), 405 days (cohort 2), 404 days (cohort 3), 191 days (cohort 4), 196 days (cohort 5), 194 days (cohort 6) and 54 days (cohort 7).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Rhabdomyosarcoma (RMS)

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

2 / 1212 / 123 / 12
Cohort 2: Nonrhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

5 / 1111 / 110 / 11
Cohort 3: Ewing Sarcoma/pPNET (Ewing)

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

3 / 1010 / 101 / 10
Cohort 4 (Osteosarcoma)

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

3 / 1010 / 103 / 10
Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

0 / 44 / 40 / 4
Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

1 / 44 / 41 / 4
Cohort 7 (Hepatoblastoma)

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

3 / 66 / 61 / 6
All Subjects

Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.

17 / 5757 / 579 / 57

Group identifiers: EG000: Cohort 1: Rhabdomyosarcoma (RMS) · EG001: Cohort 2: Nonrhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS) · EG002: Cohort 3: Ewing Sarcoma/pPNET (Ewing) · EG003: Cohort 4 (Osteosarcoma) · EG004: Cohort 5: Measurable Neuroblastoma (mNeuroblastoma) · EG005: Cohort 6: Evaluable Neuroblastoma (eNeuroblastma) · EG006: Cohort 7 (Hepatoblastoma) · EG007: All Subjects

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 (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Cardiopulmonary failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Left ventricular dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Rectal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Cellulitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Upper respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Wound infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Wound dehiscence

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 (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      12
      num At Risk
      57
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      57
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      57
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Sinus bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      57
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Supraventricular extrasystoles
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Cerumen impaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Deafness bilateral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Vertigo
Complete source fields
description
Any sign and symptom that occurs during the study treatment plus the 30 days post-treatment. Maximum exposure to study treatments = 889 days (cohort 1), 405 days (cohort 2), 404 days (cohort 3), 191 days (cohort 4), 196 days (cohort 5), 194 days (cohort 6) and 54 days (cohort 7).
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    12
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    Cohort 1: Rhabdomyosarcoma (RMS)
  2. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Cohort 2: Nonrhabdomyosarcomatous Soft Tissue Sarcoma (NRSTS)
  3. deaths Num Affected
    1
    deaths Num At Risk
    10
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    Cohort 3: Ewing Sarcoma/pPNET (Ewing)
  4. deaths Num Affected
    3
    deaths Num At Risk
    10
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    Cohort 4 (Osteosarcoma)
  5. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Cohort 5: Measurable Neuroblastoma (mNeuroblastoma)
  6. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Cohort 6: Evaluable Neuroblastoma (eNeuroblastma)
  7. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Cohort 7 (Hepatoblastoma)
  8. deaths Num Affected
    9
    deaths Num At Risk
    57
    description
    Subjects were treated with pazopanib GW786034 tablets at a dose of 450 mg/m\^2/dose or as a powder in suspension at a dose of 225 mg/m\^2/dose. The maximum daily dose administered was to be 800 mg for the tablet and 400 mg for suspension. If 225 mg/m\^2/dose was not tolerated (\>=2 DLTs in 6 evaluable subjects), the dose for subjects who required suspension was reduced to 160 mg/m\^2/dose. A cycle was defined as 28 days with no rest periods between cycles.
    id
    EG007
    other Num Affected
    57
    other Num At Risk
    57
    serious Num Affected
    17
    serious Num At Risk
    57
    title
    All Subjects
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      12
      num At Risk
      57
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      57
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      57
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Sinus bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      57
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Supraventricular extrasystoles
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Cerumen impaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Deafness bilateral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Vertigo
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Cardiopulmonary failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Left ventricular dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Rectal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Cellulitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Upper respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Wound infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      57
    term
    Wound dehiscence
time Frame
Adverse Events were collected from first dose of study treatment plus 30 days post treatment, up to a maximum duration of 889 days.

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

Preserved source evidence · Not medical advice