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NCT00012298 · ADVERSE EVENTS

Adverse events

Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2018-08-09

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
Baseline to 30 days post treatment, up to 3 years
Other-event reporting threshold
0%

Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment: Trial 1, Dose Level 1

0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

4 / 1111 / 11Not reported / Not reported
Treatment: Trial 1, Dose Level 2

0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

5 / 77 / 7Not reported / Not reported
Treatment: Trial 2, Dose Level 3

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

4 / 99 / 9Not reported / Not reported
Treatment: Trial 2, Dose Level 4

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

2 / 44 / 4Not reported / Not reported
Treatment: Trial 3, Dose Level 5

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

1 / 55 / 5Not reported / Not reported
Treatment: Trial 3, Dose Level 6

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

1 / 66 / 6Not reported / Not reported
Treatment : Phase II (Dose Level 6)

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

6 / 3939 / 39Not reported / Not reported

Group identifiers: EG000: Treatment: Trial 1, Dose Level 1 · EG001: Treatment: Trial 1, Dose Level 2 · EG002: Treatment: Trial 2, Dose Level 3 · EG003: Treatment: Trial 2, Dose Level 4 · EG004: Treatment: Trial 3, Dose Level 5 · EG005: Treatment: Trial 3, Dose Level 6 · EG006: Treatment : Phase II (Dose Level 6)

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 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    General disorders and administration site conditions - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Infections and infestations - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Wound infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
      num Events
      21
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      39
      num Events
      18
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      39
      num Events
      15
    term
    Platelet count decreased

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 12
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      93
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
      num Events
      90
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      9
      num Events
      57
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      51
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      5
      num Events
      33
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      6
      num Events
      72
    7. group Id
      EG006
      num Affected
      34
      num At Risk
      39
      num Events
      330
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      39
      num Events
      3
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      9
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      15
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
      num Events
      12
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
      num Events
      18
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      39
      num Events
      33
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      39
      num Events
      3
    term
    Ear pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Endocrine disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blurred vision
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      39
      num Events
      3
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Dry eye
Complete source fields
description
Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
event Groups
  1. description
    0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Treatment: Trial 1, Dose Level 1
  2. description
    0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Treatment: Trial 1, Dose Level 2
  3. description
    50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    EG002
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Treatment: Trial 2, Dose Level 3
  4. description
    50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Treatment: Trial 2, Dose Level 4
  5. description
    50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Treatment: Trial 3, Dose Level 5
  6. description
    50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Treatment: Trial 3, Dose Level 6
  7. description
    50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    EG006
    other Num Affected
    39
    other Num At Risk
    39
    serious Num Affected
    6
    serious Num At Risk
    39
    title
    Treatment : Phase II (Dose Level 6)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      11
      num Events
      93
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      7
      num Events
      90
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      9
      num Events
      57
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      51
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      5
      num Events
      33
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      6
      num Events
      72
    7. group Id
      EG006
      num Affected
      34
      num At Risk
      39
      num Events
      330
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      39
      num Events
      3
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      9
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      15
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      5
      num Events
      12
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
      num Events
      18
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      39
      num Events
      33
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      39
      num Events
      3
    term
    Ear pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Endocrine disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blurred vision
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      39
      num Events
      3
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Dry eye
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    General disorders and administration site conditions - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Infections and infestations - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Wound infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
      num Events
      21
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      3
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      39
      num Events
      18
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      11
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
      num Events
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
      num Events
      9
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
      num Events
      6
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      39
      num Events
      15
    term
    Platelet count decreased
time Frame
Baseline to 30 days post treatment, up to 3 years

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Preserved source evidence · Not medical advice