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NCT02530476 · ADVERSE EVENTS

Adverse events

Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia · Source last updated 2020-03-31

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
2 years, 7 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I Group 1 Selinexor + Sorafenib

Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.

4 / 43 / 41 / 4
Phase I Group 2 Selinexor + Sorafenib

Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.

3 / 33 / 30 / 3
Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)

Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.

6 / 66 / 72 / 7
Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)

Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.

3 / 31 / 32 / 3

Group identifiers: EG000: Phase I Group 1 Selinexor + Sorafenib · EG001: Phase I Group 2 Selinexor + Sorafenib · EG002: Cohort 1 (FLT3-ITD Inhibitor Failure Cohort) · EG003: Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute Kidney Injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Bronchopulmonary Hemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Dehydration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Epistaxis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Febrile Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Gastrointestinal Disorders Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Administration Site Conditions
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Hyponatremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      3
    term
    Infections

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute Kidney Injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cardiac Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Confusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hyperbilirubinemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Infection Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Nausea/Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Weakness
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    4
    serious Num At Risk
    4
    title
    Phase I Group 1 Selinexor + Sorafenib
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Phase I Group 2 Selinexor + Sorafenib
  3. deaths Num Affected
    2
    deaths Num At Risk
    7
    description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    6
    title
    Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)
  4. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Selinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I. Sorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute Kidney Injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Adrenal insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Cardiac Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Confusion
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hyperbilirubinemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Infection Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Nausea/Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Weakness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Acute Kidney Injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Bronchopulmonary Hemorrhage
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Dehydration
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Epistaxis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Febrile Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Gastrointestinal Disorders Other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Administration Site Conditions
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    term
    Hyponatremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      3
    term
    Infections
time Frame
2 years, 7 months

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Preserved source evidence · Not medical advice