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NCT02323880 · ADVERSE EVENTS

Adverse events

Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas · Source last updated 2025-01-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 7 years 8 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
Part A: Dose Level 1

35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (pre-amendment #1)

1 / 66 / 60 / 6
Part A: Dose Level 1 (DL1)(Amendment 1)

Amendment 1- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (amendment #1)

5 / 1313 / 131 / 13
Part A: Dose Level -1 (DL-1)

20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course

3 / 66 / 60 / 6
Part A: Weekly Dose Level 1 (WDL 1)

45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle

2 / 66 / 60 / 6
Part A: Weekly Dose Level -1 (WDL -1)

35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle

3 / 66 / 60 / 6
Part B: Weekly Dose Level -1 (WDL -1)

35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle

3 / 1010 / 102 / 10
Part PK: Dose Level -1 (DL -1)

20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course

0 / 66 / 60 / 6
Part PK: Weekly Dose Level -1 (DL -1)

35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle

3 / 66 / 60 / 6

Group identifiers: EG000: Part A: Dose Level 1 · EG001: Part A: Dose Level 1 (DL1)(Amendment 1) · EG002: Part A: Dose Level -1 (DL-1) · EG003: Part A: Weekly Dose Level 1 (WDL 1) · EG004: Part A: Weekly Dose Level -1 (WDL -1) · EG005: Part B: Weekly Dose Level -1 (WDL -1) · EG006: Part PK: Dose Level -1 (DL -1) · EG007: Part PK: Weekly Dose Level -1 (DL -1)

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
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Aspiration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Blurred vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Cognitive disturbance
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Depressed level of consciousness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Dysarthria
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Edema cerebral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Encephalopathy

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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Abducens nerve disorder
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Accessory nerve disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Acoustic nerve disorder NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Adrenal insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Agitation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Allergic rhinitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Alopecia
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
    0
    deaths Num At Risk
    6
    description
    35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (pre-amendment #1)
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Part A: Dose Level 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    Amendment 1- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (amendment #1)
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    5
    serious Num At Risk
    13
    title
    Part A: Dose Level 1 (DL1)(Amendment 1)
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Part A: Dose Level -1 (DL-1)
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Part A: Weekly Dose Level 1 (WDL 1)
  5. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Part A: Weekly Dose Level -1 (WDL -1)
  6. deaths Num Affected
    2
    deaths Num At Risk
    10
    description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    EG005
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    Part B: Weekly Dose Level -1 (WDL -1)
  7. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Part PK: Dose Level -1 (DL -1)
  8. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
    id
    EG007
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Part PK: Weekly Dose Level -1 (DL -1)
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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Abducens nerve disorder
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Accessory nerve disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Acoustic nerve disorder NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Adrenal insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Agitation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Allergic rhinitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Alopecia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Aspiration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Back pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Blurred vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Cognitive disturbance
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Depressed level of consciousness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Dysarthria
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    term
    Edema cerebral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    term
    Encephalopathy
time Frame
Up to 7 years 8 months

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Preserved source evidence · Not medical advice