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NCT01915498 · ADVERSE EVENTS

Adverse events

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

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
All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)
Other-event reporting threshold
5%

All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1 Dose Escalation: Enasidenib 30 mg BID

Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

6 / 77 / 76 / 7
Phase 1 Dose Escalation: Enasidenib 50 mg BID

Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

6 / 77 / 73 / 7
Phase 1 Dose Escalation: Enasidenib 75 mg BID

Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

6 / 77 / 77 / 7
Phase 1 Dose Escalation: Enasidenib 100 mg BID

Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

7 / 88 / 85 / 8
Phase 1 Dose Escalation: Enasidenib 150 mg BID

Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

3 / 55 / 53 / 5
Phase 1 Dose Escalation: Enasidenib 50 mg QD

Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

9 / 98 / 98 / 9
Phase 1 Dose Escalation: Enasidenib 75 mg QD

Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

5 / 77 / 76 / 7
Phase 1 Dose Escalation: Enasidenib 100 mg QD

Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

19 / 2222 / 2220 / 22
Phase 1 Dose Escalation: Enasidenib 150 mg QD

Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

4 / 66 / 64 / 6
Phase 1 Dose Escalation: Enasidenib 200 mg QD

Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

11 / 1414 / 147 / 14
Phase 1 Dose Escalation: Enasidenib 300 mg QD

Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

7 / 99 / 98 / 9
Phase 1 Dose Escalation: Enasidenib 450 mg QD

Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

5 / 55 / 53 / 5
Phase 1 Dose Escalation: Enasidenib 650 mg QD

Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

6 / 77 / 75 / 7
Ph1Exp Arm 1 (R/R AML Age >=60 or R From BMT)

Participants ≥ 60 years old with relapsed, refractory (R/R) AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

43 / 5050 / 5040 / 50
Ph1Exp Arm 2 (R/R AML Excluding Arm 1)

Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

18 / 2423 / 2415 / 24
Ph1Exp Arm 3 (Untrt AML Age >=60 No SOC Chemo)

Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

20 / 2525 / 2520 / 25
Ph1Exp Arm 4 (Not Eligible for Arms 1 to 3)

Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

20 / 2727 / 2717 / 27
Phase 2: Enasidenib 100 mg QD

Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

86 / 106106 / 10683 / 106

Group identifiers: EG000: Phase 1 Dose Escalation: Enasidenib 30 mg BID · EG001: Phase 1 Dose Escalation: Enasidenib 50 mg BID · EG002: Phase 1 Dose Escalation: Enasidenib 75 mg BID · EG003: Phase 1 Dose Escalation: Enasidenib 100 mg BID · EG004: Phase 1 Dose Escalation: Enasidenib 150 mg BID · EG005: Phase 1 Dose Escalation: Enasidenib 50 mg QD · EG006: Phase 1 Dose Escalation: Enasidenib 75 mg QD · EG007: Phase 1 Dose Escalation: Enasidenib 100 mg QD · EG008: Phase 1 Dose Escalation: Enasidenib 150 mg QD · EG009: Phase 1 Dose Escalation: Enasidenib 200 mg QD · EG010: Phase 1 Dose Escalation: Enasidenib 300 mg QD · EG011: Phase 1 Dose Escalation: Enasidenib 450 mg QD · EG012: Phase 1 Dose Escalation: Enasidenib 650 mg QD · EG013: Ph1Exp Arm 1 (R/R AML Age >=60 or R From BMT) · EG014: Ph1Exp Arm 2 (R/R AML Excluding Arm 1) · EG015: Ph1Exp Arm 3 (Untrt AML Age >=60 No SOC Chemo) · EG016: Ph1Exp Arm 4 (Not Eligible for Arms 1 to 3) · EG017: Phase 2: Enasidenib 100 mg QD

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
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    BONE MARROW FAILURE
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    FEBRILE BONE MARROW APLASIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    HAEMOLYSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LEUKOCYTOSIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LEUKOSTASIS SYNDROME
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHADENITIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHADENOPATHY
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    NEUTROPENIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    PANCYTOPENIA

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
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      5
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    BLOOD LOSS ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    COAGULOPATHY
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    EOSINOPHILIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LEUKOCYTOSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    LEUKOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHADENOPATHY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      5
    term
    NEUTROPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    SPLENOMEGALY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    THROMBOCYTOPENIA
Complete source fields
description
All cause Mortality, SAEs and Non SAEs was collected for treated population. A participant in Arm 2 was transferred to Arm 1 due to technical reasons after primary completion date and data collection for safety was conducted in the same arm.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    Phase 1 Dose Escalation: Enasidenib 30 mg BID
  2. deaths Num Affected
    3
    deaths Num At Risk
    7
    description
    Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    Phase 1 Dose Escalation: Enasidenib 50 mg BID
  3. deaths Num Affected
    7
    deaths Num At Risk
    7
    description
    Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    Phase 1 Dose Escalation: Enasidenib 75 mg BID
  4. deaths Num Affected
    5
    deaths Num At Risk
    8
    description
    Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG003
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    7
    serious Num At Risk
    8
    title
    Phase 1 Dose Escalation: Enasidenib 100 mg BID
  5. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Phase 1 Dose Escalation: Enasidenib 150 mg BID
  6. deaths Num Affected
    8
    deaths Num At Risk
    9
    description
    Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG005
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    9
    serious Num At Risk
    9
    title
    Phase 1 Dose Escalation: Enasidenib 50 mg QD
  7. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG006
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Phase 1 Dose Escalation: Enasidenib 75 mg QD
  8. deaths Num Affected
    20
    deaths Num At Risk
    22
    description
    Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG007
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    19
    serious Num At Risk
    22
    title
    Phase 1 Dose Escalation: Enasidenib 100 mg QD
  9. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG008
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Phase 1 Dose Escalation: Enasidenib 150 mg QD
  10. deaths Num Affected
    7
    deaths Num At Risk
    14
    description
    Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG009
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    11
    serious Num At Risk
    14
    title
    Phase 1 Dose Escalation: Enasidenib 200 mg QD
  11. deaths Num Affected
    8
    deaths Num At Risk
    9
    description
    Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG010
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    7
    serious Num At Risk
    9
    title
    Phase 1 Dose Escalation: Enasidenib 300 mg QD
  12. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    EG011
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Phase 1 Dose Escalation: Enasidenib 450 mg QD
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      5
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    BLOOD LOSS ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    COAGULOPATHY
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    EOSINOPHILIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LEUKOCYTOSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    LEUKOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHADENOPATHY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      5
    term
    NEUTROPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    SPLENOMEGALY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    THROMBOCYTOPENIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    BONE MARROW FAILURE
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    FEBRILE BONE MARROW APLASIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    HAEMOLYSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LEUKOCYTOSIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LEUKOSTASIS SYNDROME
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHADENITIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    LYMPHADENOPATHY
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    NEUTROPENIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      8
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      22
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      14
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    PANCYTOPENIA
time Frame
All cause Mortality, SAEs and Non SAEs were collected from first dose of IP to 28 days after last dose (Up to approximately 100 months)

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Preserved source evidence · Not medical advice