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NCT04154189 · ADVERSE EVENTS

Adverse events

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma · Source last updated 2024-07-22

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
From first dose up to 30 days after the last dose of study drug (up to 40.8 months)
Other-event reporting threshold
5%

Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide

Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.

30 / 3938 / 3925 / 40
Treatment Arm B: Ifosfamide + Etoposide

Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.

20 / 3939 / 3925 / 41
Treatment Arm B: Ifosfamide+Etoposide to Lenvatinib (Optional)

Eligible participants from Treatment Arm B: Ifosfamide+Etoposide who had PD per RECIST v1.1 received an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.

10 / 1616 / 1612 / 16

Group identifiers: EG000: Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide · EG001: Treatment Arm B: Ifosfamide + Etoposide · EG002: Treatment Arm B: Ifosfamide+Etoposide to Lenvatinib (Optional)

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      39
      num Events
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      39
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Anal fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Catheter site ulcer

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      39
      num Events
      180
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      39
      num Events
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      39
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      39
      num Events
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      39
      num Events
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      39
      num Events
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      39
      num Events
      39
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      39
      num Events
      20
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      39
      num Events
      50
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      39
      num Events
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      16
      num Events
      9
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Eye pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      39
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      12
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
      num Events
      3
    term
    Abdominal pain upper
Complete source fields
description
Treatment Arm B safety data for Ifosfamide + Etoposide to Lenvatinib (optional) were reported separately. All randomized participants were monitored for death (all-cause mortality). Only treated participants were assessed for adverse events (serious and non-serious).
event Groups
  1. deaths Num Affected
    25
    deaths Num At Risk
    40
    description
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    39
    serious Num Affected
    30
    serious Num At Risk
    39
    title
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
  2. deaths Num Affected
    25
    deaths Num At Risk
    41
    description
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    20
    serious Num At Risk
    39
    title
    Treatment Arm B: Ifosfamide + Etoposide
  3. deaths Num Affected
    12
    deaths Num At Risk
    16
    description
    Eligible participants from Treatment Arm B: Ifosfamide+Etoposide who had PD per RECIST v1.1 received an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    id
    EG002
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    10
    serious Num At Risk
    16
    title
    Treatment Arm B: Ifosfamide+Etoposide to Lenvatinib (Optional)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      39
      num Events
      180
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      39
      num Events
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      39
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      39
      num Events
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      39
      num Events
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
      num Events
      2
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      39
      num Events
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      39
      num Events
      39
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      39
      num Events
      20
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      3
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      39
      num Events
      50
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      39
      num Events
      52
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      16
      num Events
      9
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      39
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Eye pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      39
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      16
      num Events
      12
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      39
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
      num Events
      3
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      39
      num Events
      27
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      39
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      39
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Anal fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      39
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
      num Events
      1
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      39
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
      num Events
      0
    term
    Catheter site ulcer
time Frame
From first dose up to 30 days after the last dose of study drug (up to 40.8 months)

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Preserved source evidence · Not medical advice