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NCT01607892 · ADVERSE EVENTS

Adverse events

Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer · Source last updated 2023-01-26

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

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

Collection time frame
From first dose of study drug administration to end of treatment (up to 27 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Diffuse Large B-cell Lymphoma (DLBCL)

Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \<= 12 milligram per square meter (mg/m\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

33 / 5858 / 58Not reported / Not reported
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL

Participants with NHL received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly \[1 Day between doses\] during weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

7 / 2727 / 27Not reported / Not reported
Multiple Myeloma (MM)

Participants with MM received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\^2 total) in the 1-week run-in period; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \>= 35 mg/m\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.

52 / 8180 / 81Not reported / Not reported
Acute Myeloid Leukemia (AML)

Participants with AML received Selinexor in different Schedules; Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \>= 55 mg/m\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.

73 / 9594 / 95Not reported / Not reported
Other Hematological Malignancies (ALL, CML and CLL)

Participants with other hematological malignancies (Acute lymphoblastic leukemia \[ALL\], Chronic myelogenous leukemia \[CML\] and chronic lymphocytic leukemia \[CLL\]) received Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly \[1 day between doses\]; Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.

13 / 2424 / 24Not reported / Not reported

Group identifiers: EG000: Diffuse Large B-cell Lymphoma (DLBCL) · EG001: Non-Hodgkin Lymphoma (NHL) Excluding DLBCL · EG002: Multiple Myeloma (MM) · EG003: Acute Myeloid Leukemia (AML) · EG004: Other Hematological Malignancies (ALL, CML and CLL)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Embolism
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hypotension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Small intestinal resection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Malignant neoplasm progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Tumour pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Pyrexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Death
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Disease progression
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Multiple organ dysfunction syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Gait disturbance

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Hypotension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      24
    term
    Hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Orthostatic hypotension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hot flush
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      24
    term
    Fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Pyrexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Oedema peripheral
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Asthenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Chills
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Gait disturbance
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Malaise
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Non-cardiac chest pain
Complete source fields
event Groups
  1. description
    Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \<= 12 milligram per square meter (mg/m\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
    id
    EG000
    other Num Affected
    58
    other Num At Risk
    58
    serious Num Affected
    33
    serious Num At Risk
    58
    title
    Diffuse Large B-cell Lymphoma (DLBCL)
  2. description
    Participants with NHL received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly \[1 Day between doses\] during weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    7
    serious Num At Risk
    27
    title
    Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
  3. description
    Participants with MM received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\^2 total) in the 1-week run-in period; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \>= 35 mg/m\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
    id
    EG002
    other Num Affected
    80
    other Num At Risk
    81
    serious Num Affected
    52
    serious Num At Risk
    81
    title
    Multiple Myeloma (MM)
  4. description
    Participants with AML received Selinexor in different Schedules; Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \>= 55 mg/m\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
    id
    EG003
    other Num Affected
    94
    other Num At Risk
    95
    serious Num Affected
    73
    serious Num At Risk
    95
    title
    Acute Myeloid Leukemia (AML)
  5. description
    Participants with other hematological malignancies (Acute lymphoblastic leukemia \[ALL\], Chronic myelogenous leukemia \[CML\] and chronic lymphocytic leukemia \[CLL\]) received Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly \[1 day between doses\]; Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
    id
    EG004
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    13
    serious Num At Risk
    24
    title
    Other Hematological Malignancies (ALL, CML and CLL)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Hypotension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      24
    term
    Hypertension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Orthostatic hypotension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hot flush
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      24
    term
    Fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Pyrexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Oedema peripheral
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Asthenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Chills
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    term
    Gait disturbance
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Malaise
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Non-cardiac chest pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Embolism
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Hypotension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Small intestinal resection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Malignant neoplasm progression
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Tumour pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Pyrexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Death
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Asthenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Disease progression
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    term
    Multiple organ dysfunction syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      58
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      81
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      95
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    term
    Gait disturbance
time Frame
From first dose of study drug administration to end of treatment (up to 27 months)

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