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NCT01432600 · ADVERSE EVENTS

Adverse events

Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide · Source last updated 2017-05-23

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
4 years, 1 month
Other-event reporting threshold
0%

All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A: Dose Escalation of Cyclophosphamide

Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.

10 / 1010 / 10Not reported / Not reported
B: Pomalidomide and Dexamethasone

Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.

11 / 3635 / 36Not reported / Not reported
C: Pomalidomide, Dexamethasone, Cyclophosphamide

Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.

19 / 3433 / 34Not reported / Not reported
D: Crossover Arm

Phase II: Participants who crossed over from Arm B to Arm D.

9 / 1715 / 17Not reported / Not reported

Group identifiers: EG000: A: Dose Escalation of Cyclophosphamide · EG001: B: Pomalidomide and Dexamethasone · EG002: C: Pomalidomide, Dexamethasone, Cyclophosphamide · EG003: D: Crossover Arm

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Cardiac disorders - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Retinal vascular disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colonic hemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colonic obstruction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colonic perforation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Gastrointestinal disorders, Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Rectal hemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Fatigue

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      36
      num Events
      21
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      34
      num Events
      54
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      17
      num Events
      10
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Blood and Lymphatic System Disorders - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Spleen disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      10
      num Events
      10
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      36
      num Events
      36
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      34
      num Events
      76
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      17
      num Events
      18
    term
    Neutrophil count decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
      num Events
      10
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      36
      num Events
      15
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      34
      num Events
      46
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Platelet count decreased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      36
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      34
      num Events
      52
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
      num Events
      15
    term
    White blood cell decreased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      36
      num Events
      20
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
      num Events
      24
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
      num Events
      15
    term
    Lymphocyte count decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      36
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Weight gain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      36
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      2
    term
    Aspartate aminotransferase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Alanine aminotransferase increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Alkaline phosphatase increased
Complete source fields
description
All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
event Groups
  1. description
    Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    10
    serious Num At Risk
    10
    title
    A: Dose Escalation of Cyclophosphamide
  2. description
    Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.
    id
    EG001
    other Num Affected
    35
    other Num At Risk
    36
    serious Num Affected
    11
    serious Num At Risk
    36
    title
    B: Pomalidomide and Dexamethasone
  3. description
    Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
    id
    EG002
    other Num Affected
    33
    other Num At Risk
    34
    serious Num Affected
    19
    serious Num At Risk
    34
    title
    C: Pomalidomide, Dexamethasone, Cyclophosphamide
  4. description
    Phase II: Participants who crossed over from Arm B to Arm D.
    id
    EG003
    other Num Affected
    15
    other Num At Risk
    17
    serious Num Affected
    9
    serious Num At Risk
    17
    title
    D: Crossover Arm
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      36
      num Events
      21
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      34
      num Events
      54
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      17
      num Events
      10
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Blood and Lymphatic System Disorders - Other
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Spleen disorder
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      10
      num Events
      10
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      36
      num Events
      36
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      34
      num Events
      76
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      17
      num Events
      18
    term
    Neutrophil count decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
      num Events
      10
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      36
      num Events
      15
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      34
      num Events
      46
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      2
    term
    Platelet count decreased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      36
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      34
      num Events
      52
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      17
      num Events
      15
    term
    White blood cell decreased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      36
      num Events
      20
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
      num Events
      24
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      17
      num Events
      15
    term
    Lymphocyte count decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      36
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Weight gain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      36
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      2
    term
    Aspartate aminotransferase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Alanine aminotransferase increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Alkaline phosphatase increased
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      36
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      17
      num Events
      3
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Cardiac disorders - Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Retinal vascular disorder
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colonic hemorrhage
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colonic obstruction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Colonic perforation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Gastrointestinal disorders, Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Rectal hemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Fatigue
time Frame
4 years, 1 month

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Preserved source evidence · Not medical advice