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NCT03389802 · ADVERSE EVENTS

Adverse events

Phase I Study of APX005M in Pediatric Central Nervous System Tumors · Source last updated 2026-08-13

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
Approximately 3 years after start of treatment
Other-event reporting threshold
0%

Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.

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

Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

0 / 33 / 30 / 3
Stratum 1, Dose Level 2

Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

0 / 33 / 31 / 3
Stratum 1, Dose Level 3

Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

4 / 1414 / 145 / 14
Stratum 2, Dose Level 2

Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

1 / 66 / 64 / 6
Stratum 2, Dose Level 3

Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

5 / 55 / 54 / 5

Group identifiers: EG000: Stratum 1, Dose Level 1 · EG001: Stratum 1, Dose Level 2 · EG002: Stratum 1, Dose Level 3 · EG003: Stratum 2, Dose Level 2 · EG004: Stratum 2, Dose Level 3

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Dysphagia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Hepatic failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Allergic reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Cytokine release syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      14
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Infusion related reaction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Alanine aminotransferase increased

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      6
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      14
      num Events
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
      num Events
      9
    term
    Lymphocyte count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Myalgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Flushing
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      7
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      14
      num Events
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      5
      num Events
      7
    term
    White blood cell decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      14
      num Events
      15
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      9
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      14
      num Events
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      4
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      14
      num Events
      20
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      5
      num Events
      14
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Periorbital edema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Gastrointestinal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Mucositis oral
Complete source fields
description
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Stratum 1, Dose Level 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Stratum 1, Dose Level 2
  3. deaths Num Affected
    5
    deaths Num At Risk
    14
    description
    Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    4
    serious Num At Risk
    14
    title
    Stratum 1, Dose Level 3
  4. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Stratum 2, Dose Level 2
  5. deaths Num Affected
    4
    deaths Num At Risk
    5
    description
    Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Stratum 2, Dose Level 3
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      6
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      14
      num Events
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
      num Events
      9
    term
    Lymphocyte count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Chills
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Myalgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Flushing
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      7
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      14
      num Events
      22
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      5
      num Events
      7
    term
    White blood cell decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      14
      num Events
      15
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      9
    term
    Anemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      14
      num Events
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      4
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      14
      num Events
      20
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      6
      num Events
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      5
      num Events
      14
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Periorbital edema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Gastrointestinal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Mucositis oral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Dysphagia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Fatigue
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Hepatic failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Allergic reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Cytokine release syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Upper respiratory infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      14
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Infusion related reaction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Alanine aminotransferase increased
time Frame
Approximately 3 years after start of treatment

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Preserved source evidence · Not medical advice