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NCT00689936 · ADVERSE EVENTS

Adverse events

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma · Source last updated 2019-11-20

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

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

Collection time frame
From the first dose of treatment to at least 28 days after discontinuation of active treatment for those not continuing in the PFS phase; median duration of treatment was 80.2 weeks in the Rd arm, 72.0 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Lenalidomide and Low-Dose Dexamethasone (Rd)

Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.

378 / 532523 / 532Not reported / Not reported
Lenalidomide and Dexamethasone (Rd18)

Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.

308 / 540532 / 540Not reported / Not reported
Melphalan + Prednisone + Thalidomide (MPT)

Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.

270 / 541532 / 541Not reported / Not reported

Group identifiers: EG000: Lenalidomide and Low-Dose Dexamethasone (Rd) · EG001: Lenalidomide and Dexamethasone (Rd18) · EG002: Melphalan + Prednisone + Thalidomide (MPT)

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
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      541
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    ANAEMIA HAEMOLYTIC AUTOIMMUNE
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    FEBRILE BONE MARROW APLASIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      541
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    HAEMOLYSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    HYPERVISCOSITY SYNDROME
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    HYPOCOAGULABLE STATE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    IDIOPATHIC THROMBOCYTOPENIC PURPURA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      541
    term
    LEUKOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    LYMPHADENITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    LYMPHOPENIA

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
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      237
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      191
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      219
      num At Risk
      541
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      92
      num At Risk
      541
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      71
      num At Risk
      541
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      177
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      325
      num At Risk
      541
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      132
      num At Risk
      541
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    ATRIAL FIBRILLATION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      541
    term
    VERTIGO
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    CATARACT
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    VISION BLURRED
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      541
    term
    ABDOMINAL PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      541
    term
    ABDOMINAL PAIN UPPER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      233
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      210
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      282
      num At Risk
      541
    term
    CONSTIPATION
Complete source fields
event Groups
  1. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
    id
    EG000
    other Num Affected
    523
    other Num At Risk
    532
    serious Num Affected
    378
    serious Num At Risk
    532
    title
    Lenalidomide and Low-Dose Dexamethasone (Rd)
  2. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
    id
    EG001
    other Num Affected
    532
    other Num At Risk
    540
    serious Num Affected
    308
    serious Num At Risk
    540
    title
    Lenalidomide and Dexamethasone (Rd18)
  3. description
    Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
    id
    EG002
    other Num Affected
    532
    other Num At Risk
    541
    serious Num Affected
    270
    serious Num At Risk
    541
    title
    Melphalan + Prednisone + Thalidomide (MPT)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      237
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      191
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      219
      num At Risk
      541
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      92
      num At Risk
      541
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      71
      num At Risk
      541
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      177
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      325
      num At Risk
      541
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      99
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      132
      num At Risk
      541
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    ATRIAL FIBRILLATION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      541
    term
    VERTIGO
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    CATARACT
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    VISION BLURRED
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      541
    term
    ABDOMINAL PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      541
    term
    ABDOMINAL PAIN UPPER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      233
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      210
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      282
      num At Risk
      541
    term
    CONSTIPATION
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      541
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    ANAEMIA HAEMOLYTIC AUTOIMMUNE
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    FEBRILE BONE MARROW APLASIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      541
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    HAEMOLYSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    HYPERVISCOSITY SYNDROME
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    HYPOCOAGULABLE STATE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    IDIOPATHIC THROMBOCYTOPENIC PURPURA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      541
    term
    LEUKOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      541
    term
    LYMPHADENITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MEDDRA15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      532
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      540
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      541
    term
    LYMPHOPENIA
time Frame
From the first dose of treatment to at least 28 days after discontinuation of active treatment for those not continuing in the PFS phase; median duration of treatment was 80.2 weeks in the Rd arm, 72.0 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.

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