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NCT04256707 · ADVERSE EVENTS

Adverse events

Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment · Source last updated 2026-10-09

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
Monotherapy: From start of study drug administration (Day 1) up to survival follow-up (up to 4 months); Combination therapy: From start of study drug administration (Day 1) up to survival follow-up (up to 25 months)
Other-event reporting threshold
5%

Safety population: All participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods. Mortality data for the combination therapy evaluated all participants who received treatment, including those who moved to combination therapy during the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function

Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.

4 / 119 / 111 / 11
Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function

Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.

1 / 1111 / 111 / 11
Monotherapy: Moderate Hepatic Function (Tablet A Only)

Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablets) orally once weekly on Day 1 up to 4 months.

5 / 77 / 73 / 7
Monotherapy: Severe Hepatic Function (Tablet A Only)

Participants with severe hepatic function received Tablet A (selinexor 2 X 20 mg tablets) orally once weekly on Day 1 up to 4 months.

1 / 64 / 65 / 6
Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel

Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks up to 25 months.

11 / 1717 / 1711 / 17
Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab

Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks up to 25 months.

10 / 3837 / 3830 / 38
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)

Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.

2 / 66 / 65 / 6
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)

Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.

1 / 22 / 22 / 2

Group identifiers: EG000: Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function · EG001: Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function · EG002: Monotherapy: Moderate Hepatic Function (Tablet A Only) · EG003: Monotherapy: Severe Hepatic Function (Tablet A Only) · EG004: Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel · EG005: Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab · EG006: Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) · EG007: Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Intestinal perforation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Upper gastrointestinal haemorrhage
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Cholangitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Cholecystitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Device related infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Respiratory tract infection viral
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Femur fracture
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Oxygen saturation decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Hyponatraemia

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    term
    Leukocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    term
    Neutrophilia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Arrhythmia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Myocardial infarction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Deafness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Hypoacusis
Complete source fields
description
Safety population: All participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods. Mortality data for the combination therapy evaluated all participants who received treatment, including those who moved to combination therapy during the study.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    11
    description
    Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
    id
    EG000
    other Num Affected
    9
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function
  2. deaths Num Affected
    1
    deaths Num At Risk
    11
    description
    Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    1
    serious Num At Risk
    11
    title
    Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function
  3. deaths Num Affected
    3
    deaths Num At Risk
    7
    description
    Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablets) orally once weekly on Day 1 up to 4 months.
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Monotherapy: Moderate Hepatic Function (Tablet A Only)
  4. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Participants with severe hepatic function received Tablet A (selinexor 2 X 20 mg tablets) orally once weekly on Day 1 up to 4 months.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Monotherapy: Severe Hepatic Function (Tablet A Only)
  5. deaths Num Affected
    11
    deaths Num At Risk
    17
    description
    Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks up to 25 months.
    id
    EG004
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    11
    serious Num At Risk
    17
    title
    Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel
  6. deaths Num Affected
    30
    deaths Num At Risk
    38
    description
    Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks up to 25 months.
    id
    EG005
    other Num Affected
    37
    other Num At Risk
    38
    serious Num Affected
    10
    serious Num At Risk
    38
    title
    Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab
  7. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)
  8. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
    id
    EG007
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    term
    Leukocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    term
    Neutrophilia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Arrhythmia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Myocardial infarction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Deafness
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Hypoacusis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Intestinal perforation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Upper gastrointestinal haemorrhage
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Cholangitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Cholecystitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Device related infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Respiratory tract infection viral
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Femur fracture
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Oxygen saturation decreased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      17
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      38
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    term
    Hyponatraemia
time Frame
Monotherapy: From start of study drug administration (Day 1) up to survival follow-up (up to 4 months); Combination therapy: From start of study drug administration (Day 1) up to survival follow-up (up to 25 months)

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