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NCT01482962 · ADVERSE EVENTS

Adverse events

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma · Source last updated 2018-07-31

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

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

Collection time frame
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)
Other-event reporting threshold
5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Alisertib

Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).

75 / 137134 / 13711 / 137
Gemcitabine

Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks).

18 / 2929 / 295 / 29
Pralatrexate

Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks).

46 / 7672 / 768 / 76
Romidepsin

Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).

6 / 2221 / 222 / 22

Group identifiers: EG000: Alisertib · EG001: Gemcitabine · EG002: Pralatrexate · EG003: Romidepsin

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
    notes
    One treatment-emergent death occurred during treatment with alisertib and is related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Lung infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Lower respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with alisertib and is not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Four treatment-emergent deaths occurred during treatment with alisertib, two related and two not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with pralatrexate and is not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Skin infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Dermatitis infected
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Epiglottitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Tonsillitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Cytomegalovirus infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Cytomegalovirus chorioretinitis

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      22
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    term
    Stomatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      22
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      22
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      22
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Mouth ulceration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Odynophagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      22
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      22
    term
    Neutropenia
Complete source fields
description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events for arm "Gemcitabine or Pralatrexate or Romidepsin" were reported separately for each treatment received and reported as Gemcitabine, Pralatrexate, and Romidepsin.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    137
    description
    Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
    id
    EG000
    other Num Affected
    134
    other Num At Risk
    137
    serious Num Affected
    75
    serious Num At Risk
    137
    title
    Alisertib
  2. deaths Num Affected
    5
    deaths Num At Risk
    29
    description
    Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks).
    id
    EG001
    other Num Affected
    29
    other Num At Risk
    29
    serious Num Affected
    18
    serious Num At Risk
    29
    title
    Gemcitabine
  3. deaths Num Affected
    8
    deaths Num At Risk
    76
    description
    Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks).
    id
    EG002
    other Num Affected
    72
    other Num At Risk
    76
    serious Num Affected
    46
    serious Num At Risk
    76
    title
    Pralatrexate
  4. deaths Num Affected
    2
    deaths Num At Risk
    22
    description
    Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    6
    serious Num At Risk
    22
    title
    Romidepsin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      22
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    term
    Stomatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      22
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      22
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      22
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Mouth ulceration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Odynophagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      22
    term
    Anaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      22
    term
    Neutropenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with alisertib and is related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Lung infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Lower respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with alisertib and is not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Four treatment-emergent deaths occurred during treatment with alisertib, two related and two not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One treatment-emergent death occurred during treatment with pralatrexate and is not related.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Skin infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Dermatitis infected
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Epiglottitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Tonsillitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Cytomegalovirus infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA version 15.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      137
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
    term
    Cytomegalovirus chorioretinitis
time Frame
First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)

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Preserved source evidence · Not medical advice