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NCT02113982 · ADVERSE EVENTS

Adverse events

Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia · Source last updated 2024-08-01

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

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

Collection time frame
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months
Other-event reporting threshold
5%

Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Stage 1 - AML Indication: 7 µg/kg/Day Dosage

All AML study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

2 / 33 / 30 / 3
Stage 1 - AML Indication: 9 µg/kg/Day Dosage

All AML study patients who received 9 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

3 / 33 / 30 / 3
Stage 1 - AML Indication: 12 µg/kg/Day Dosage

All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

2 / 22 / 21 / 2
Stage 1 - AML Indication: 16 µg/kg/Day Dosage

All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

6 / 66 / 64 / 6
1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage

All BPDCN study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

1 / 33 / 31 / 3
1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage

All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

1 / 33 / 30 / 3
R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage

All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

3 / 33 / 31 / 3
Stage 2 - AML Indication: 12 µg/kg/Day Dosage

All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

19 / 3434 / 343 / 34
Stage 2 - AML Indication: 16 µg/kg/Day Dosage

All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

1 / 11 / 10 / 1
1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage

All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

7 / 1313 / 131 / 13
R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage

All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

6 / 1010 / 100 / 10
1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage

All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

4 / 1313 / 131 / 13
1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage

All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

20 / 3737 / 373 / 37
R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage

All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle

5 / 77 / 72 / 7

Group identifiers: EG000: Stage 1 - AML Indication: 7 µg/kg/Day Dosage · EG001: Stage 1 - AML Indication: 9 µg/kg/Day Dosage · EG002: Stage 1 - AML Indication: 12 µg/kg/Day Dosage · EG003: Stage 1 - AML Indication: 16 µg/kg/Day Dosage · EG004: 1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage · EG005: 1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage · EG006: R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage · EG007: Stage 2 - AML Indication: 12 µg/kg/Day Dosage · EG008: Stage 2 - AML Indication: 16 µg/kg/Day Dosage · EG009: 1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage · EG010: R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage · EG011: 1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage · EG012: 1L - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage · EG013: R/R - Stage 4 - BPDCN Indication: 12 µg/kg/Day Dosage

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
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Gastritis haemorrhagic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Upper gastrointestinal haemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Disease progression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Hepatic failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Empyema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Escherichia bacteraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Infusion related reaction

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
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      13
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      13
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Lymphocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Lymphopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      13
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Atrial flutter
Complete source fields
description
Considering only 15% of overall patients enrolled across the different stages of the study were treated with dose other than 12µg/kg/day, reporting the adverse events by indication instead of dose level is considered more relevant for safety purpose. The safety population was defined as all patients enrolled in the study who received at least 1 dose of Tagraxofusp; all 138 patients were in the safety population, including 69 first-line BPDCN patients, 20 R/R BPDCN patients, and 49 AML patients.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    All AML study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Stage 1 - AML Indication: 7 µg/kg/Day Dosage
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    All AML study patients who received 9 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Stage 1 - AML Indication: 9 µg/kg/Day Dosage
  3. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Stage 1 - AML Indication: 12 µg/kg/Day Dosage
  4. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    6
    serious Num At Risk
    6
    title
    Stage 1 - AML Indication: 16 µg/kg/Day Dosage
  5. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    All BPDCN study patients who received 7 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    1L - Stage 1 - BPDCN Indication: 7 µg/kg/Day Dosage
  6. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG005
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    1L - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
  7. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    R/R - Stage 1 - BPDCN Indication: 12 µg/kg/Day Dosage
  8. deaths Num Affected
    3
    deaths Num At Risk
    34
    description
    All AML study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG007
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    19
    serious Num At Risk
    34
    title
    Stage 2 - AML Indication: 12 µg/kg/Day Dosage
  9. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    All AML study patients who received 16 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG008
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Stage 2 - AML Indication: 16 µg/kg/Day Dosage
  10. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG009
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    7
    serious Num At Risk
    13
    title
    1L - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
  11. deaths Num Affected
    0
    deaths Num At Risk
    10
    description
    All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG010
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    R/R - Stage 2 - BPDCN Indication: 12 µg/kg/Day Dosage
  12. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    All BPDCN study patients who received 12 µg/kg/day of tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    EG011
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    1L - Stage 3 - BPDCN Indication: 12 µg/kg/Day Dosage
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      13
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      13
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Lymphocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Lymphopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      4
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      5
      num At Risk
      13
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Atrial flutter
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      13
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Gastritis haemorrhagic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Upper gastrointestinal haemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Disease progression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Hepatic failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Empyema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Escherichia bacteraemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (19.0)
    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
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      34
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      13
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      10
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      13
    term
    Infusion related reaction
time Frame
From first dose until 30 days after treatment infusion with the longest treatment exposure of 53.3 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice