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NCT04447755 · ADVERSE EVENTS

Adverse events

A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) · Source last updated 2025-10-03

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
Up to approximately 50 months
Other-event reporting threshold
5%

The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.

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

Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.

4 / 99 / 99 / 9
Rhabdomyosarcoma

Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

5 / 1717 / 1717 / 17
High Grade Glioma

Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

6 / 86 / 88 / 8
Diffuse Midline Glioma

Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

4 / 99 / 99 / 9
Medulloblastoma

Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

4 / 99 / 98 / 9
Ependymoma

Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

4 / 97 / 99 / 9
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma

Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

39 / 6666 / 6655 / 66

Group identifiers: EG000: Ewing Sarcoma · EG001: Rhabdomyosarcoma · EG002: High Grade Glioma · EG003: Diffuse Midline Glioma · EG004: Medulloblastoma · EG005: Ependymoma · EG006: Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Inappropriate antidiuretic hormone secretion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Orbital compartment syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      66
      num Events
      3
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Anal fistula
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Duodenal perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Enteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Enterocolitis

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      66
      num Events
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      66
      num Events
      13
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Cardiac dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      2
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Sinus bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      66
      num Events
      5
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Ear haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Excessive cerumen production
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      66
      num Events
      2
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Adrenal insufficiency
Complete source fields
description
The analysis population for All-Cause Mortality included all allocated participants. The safety analysis population included all allocated participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    9
    description
    Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
    id
    EG000
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Ewing Sarcoma
  2. deaths Num Affected
    17
    deaths Num At Risk
    17
    description
    Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    EG001
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    5
    serious Num At Risk
    17
    title
    Rhabdomyosarcoma
  3. deaths Num Affected
    8
    deaths Num At Risk
    8
    description
    Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    8
    serious Num Affected
    6
    serious Num At Risk
    8
    title
    High Grade Glioma
  4. deaths Num Affected
    9
    deaths Num At Risk
    9
    description
    Participants with diffuse midline glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Diffuse Midline Glioma
  5. deaths Num Affected
    8
    deaths Num At Risk
    9
    description
    Participants with medulloblastoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    EG004
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Medulloblastoma
  6. deaths Num Affected
    9
    deaths Num At Risk
    9
    description
    Participants with ependymoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    EG005
    other Num Affected
    7
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Ependymoma
  7. deaths Num Affected
    55
    deaths Num At Risk
    66
    description
    Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    EG006
    other Num Affected
    66
    other Num At Risk
    66
    serious Num Affected
    39
    serious Num At Risk
    66
    title
    Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      17
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      66
      num Events
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      66
      num Events
      13
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Cardiac dysfunction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      2
    term
    Pericardial effusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Sinus bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      66
      num Events
      5
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Ear haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      17
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Excessive cerumen production
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      66
      num Events
      2
    term
    Vertigo
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Adrenal insufficiency
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Inappropriate antidiuretic hormone secretion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Orbital compartment syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      66
      num Events
      3
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Anal fistula
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      66
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Duodenal perforation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Enteritis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      17
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Enterocolitis
time Frame
Up to approximately 50 months

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Preserved source evidence · Not medical advice