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NCT01713582 · ADVERSE EVENTS

Adverse events

A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/ Birabresib (MK-8628) in Hematologic Malignancies (MK-8628-001) · Source last updated 2021-01-26

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

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

Collection time frame
Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).
Other-event reporting threshold
0%

The safety population consisted of all participants who received at least one dose of study therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AL 10 mg QD 14-21

Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.

1 / 33 / 33 / 3
AL 20 mg QD 14-21

Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

2 / 33 / 33 / 3
AL 40 mg QD 14-21

Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

3 / 44 / 44 / 4
AL 20 mg BID 21-21

Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.

1 / 33 / 33 / 3
AL 80 mg QD 14-21

Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

3 / 44 / 44 / 4
AL 40 mg BID 14-21

Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.

7 / 88 / 87 / 8
AL 120 mg QD 14-21

Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

6 / 77 / 77 / 7
AL 120 mg QD 21-21

Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.

5 / 66 / 66 / 6
AL 160 mg QD 14-21

Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

4 / 66 / 66 / 6
AML de Novo 80 mg QD 14-21

Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

14 / 1818 / 1815 / 18
AML/MDS 80 mg QD 14-21

Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

14 / 1616 / 1615 / 16
OHM 10 mg QD 21-21

Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.

3 / 55 / 53 / 5
OHM 20 mg QD 21-21

Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.

1 / 33 / 32 / 3
OHM 40 mg QD 21-21

Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.

0 / 44 / 42 / 4
OHM 40 mg BID 21-21

Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.

5 / 66 / 64 / 6
OHM 120 mg QD 21-21

Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.

6 / 77 / 75 / 7
OHM 120 mg QD 14-21

Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

2 / 33 / 31 / 3
OHM 120 mg QD 5-7

Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.

2 / 55 / 52 / 5
OHM 120 mg QD 7-21

Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.

2 / 55 / 55 / 5
OHM/DLBCL 80 mg QD 14-21

Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.

5 / 1515 / 159 / 15
OHM 80 mg QD 21-21

Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.

4 / 77 / 74 / 7

Group identifiers: EG000: AL 10 mg QD 14-21 · EG001: AL 20 mg QD 14-21 · EG002: AL 40 mg QD 14-21 · EG003: AL 20 mg BID 21-21 · EG004: AL 80 mg QD 14-21 · EG005: AL 40 mg BID 14-21 · EG006: AL 120 mg QD 14-21 · EG007: AL 120 mg QD 21-21 · EG008: AL 160 mg QD 14-21 · EG009: AML de Novo 80 mg QD 14-21 · EG010: AML/MDS 80 mg QD 14-21 · EG011: OHM 10 mg QD 21-21 · EG012: OHM 20 mg QD 21-21 · EG013: OHM 40 mg QD 21-21 · EG014: OHM 40 mg BID 21-21 · EG015: OHM 120 mg QD 21-21 · EG016: OHM 120 mg QD 14-21 · EG017: OHM 120 mg QD 5-7 · EG018: OHM 120 mg QD 7-21 · EG019: OHM/DLBCL 80 mg QD 14-21 · EG020: OHM 80 mg QD 21-21

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Disseminated intravascular coagulation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Febrile bone marrow aplasia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Haemorrhagic disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Leukocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Atrial flutter
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cardiac arrest
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cardiac failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Pericardial effusion

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      9
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      7
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Disseminated intravascular coagulation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Haemorrhagic disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Leukocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Lymph node pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Splenomegaly
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Arrhythmia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Atrial fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cardiac arrest
Complete source fields
description
The safety population consisted of all participants who received at least one dose of study therapy.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    AL 10 mg QD 14-21
  2. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    AL 20 mg QD 14-21
  3. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    AL 40 mg QD 14-21
  4. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    AL 20 mg BID 21-21
  5. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    AL 80 mg QD 14-21
  6. deaths Num Affected
    7
    deaths Num At Risk
    8
    description
    Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
    id
    EG005
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    7
    serious Num At Risk
    8
    title
    AL 40 mg BID 14-21
  7. deaths Num Affected
    7
    deaths Num At Risk
    7
    description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG006
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    AL 120 mg QD 14-21
  8. deaths Num Affected
    6
    deaths Num At Risk
    6
    description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    EG007
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    AL 120 mg QD 21-21
  9. deaths Num Affected
    6
    deaths Num At Risk
    6
    description
    Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG008
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    AL 160 mg QD 14-21
  10. deaths Num Affected
    15
    deaths Num At Risk
    18
    description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG009
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    14
    serious Num At Risk
    18
    title
    AML de Novo 80 mg QD 14-21
  11. deaths Num Affected
    15
    deaths Num At Risk
    16
    description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    EG010
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    14
    serious Num At Risk
    16
    title
    AML/MDS 80 mg QD 14-21
  12. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    EG011
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    OHM 10 mg QD 21-21
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      9
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      7
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Disseminated intravascular coagulation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Haemorrhagic disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Leukocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Lymph node pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Splenomegaly
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Arrhythmia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Atrial fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cardiac arrest
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Disseminated intravascular coagulation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Febrile bone marrow aplasia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Haemorrhagic disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Leukocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Thrombocytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Atrial flutter
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cardiac arrest
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cardiac failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      6
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      18
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      16
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Pericardial effusion
time Frame
Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).

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Preserved source evidence · Not medical advice