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NCT02867592 · ADVERSE EVENTS

Adverse events

Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors · Source last updated 2026-08-28

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 start of treatment to 30 days after last dose, a median of 3.4 months
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

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

Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

6 / 135 / 1312 / 13
Rhabdomyosarcoma

Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

2 / 137 / 1310 / 13
Non-Rhabdomyosarcoma Soft Tissue Sarcoma

Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

4 / 137 / 138 / 13
Wilms Tumor

Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

6 / 137 / 1310 / 13
Rare Tumors

Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

10 / 2313 / 2318 / 23
Osteosarcoma

Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

8 / 2917 / 2920 / 29

Group identifiers: EG000: Ewing's Sarcoma · EG001: Rhabdomyosarcoma · EG002: Non-Rhabdomyosarcoma Soft Tissue Sarcoma · EG003: Wilms Tumor · EG004: Rare Tumors · EG005: Osteosarcoma

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
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Alkaline phosphatase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Blood bilirubin increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Chest wall pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Death NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Dehydration

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Alkaline phosphatase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      29
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Atelectasis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Blood bilirubin increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Chest pain - cardiac
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Diarrhea
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    13
    description
    Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    13
    serious Num Affected
    6
    serious Num At Risk
    13
    title
    Ewing's Sarcoma
  2. deaths Num Affected
    10
    deaths Num At Risk
    13
    description
    Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    13
    serious Num Affected
    2
    serious Num At Risk
    13
    title
    Rhabdomyosarcoma
  3. deaths Num Affected
    8
    deaths Num At Risk
    13
    description
    Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    Non-Rhabdomyosarcoma Soft Tissue Sarcoma
  4. deaths Num Affected
    10
    deaths Num At Risk
    13
    description
    Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    13
    serious Num Affected
    6
    serious Num At Risk
    13
    title
    Wilms Tumor
  5. deaths Num Affected
    18
    deaths Num At Risk
    23
    description
    Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG004
    other Num Affected
    13
    other Num At Risk
    23
    serious Num Affected
    10
    serious Num At Risk
    23
    title
    Rare Tumors
  6. deaths Num Affected
    20
    deaths Num At Risk
    29
    description
    Patients receive cabozantinib-s-malate (XL184), 40mg/m2/day orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    EG005
    other Num Affected
    17
    other Num At Risk
    29
    serious Num Affected
    8
    serious Num At Risk
    29
    title
    Osteosarcoma
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Alkaline phosphatase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      29
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Atelectasis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Blood bilirubin increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Chest pain - cardiac
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Dehydration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Alkaline phosphatase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Blood bilirubin increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Chest wall pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      29
    term
    Death NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      23
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      29
    term
    Dehydration
time Frame
From start of treatment to 30 days after last dose, a median of 3.4 months

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Preserved source evidence · Not medical advice