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NCT01208662 · ADVERSE EVENTS

Adverse events

Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 · Source last updated 2026-01-22

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
Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment. Maximum treatment duration was 133.5 months in this study cohort.
Other-event reporting threshold
0%

Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. This is not the same definition of SAE per protocol but parallels the publication. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. Maximum grade toxicity by type was then calculated. No further data is available to specify classification of other beyond the general term.

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

All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

279 / 357343 / 35789 / 357
RVD Plus ASCT

All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

344 / 365345 / 36588 / 365
RVD Cycle 1 Only

RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1) on days 1, 2, 4, 5, 8, 9, 11, and 12

4 / 77 / 71 / 7

Group identifiers: EG000: RVD Alone · EG001: RVD Plus ASCT · EG002: RVD Cycle 1 Only

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      108
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  3. assessment Type
    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
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      145
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    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
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      152
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      315
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Neutropenia
  8. assessment Type
    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
      357
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      302
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Acute heart failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Acute pericarditis

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
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abcess
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal crampy pains
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal discomfort
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal wall cyst
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal bowel sounds
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal sensation in ear
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal sensation of limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abrasions
Complete source fields
description
Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. This is not the same definition of SAE per protocol but parallels the publication. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. Maximum grade toxicity by type was then calculated. No further data is available to specify classification of other beyond the general term.
event Groups
  1. deaths Num Affected
    89
    deaths Num At Risk
    357
    description
    All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    EG000
    other Num Affected
    343
    other Num At Risk
    357
    serious Num Affected
    279
    serious Num At Risk
    357
    title
    RVD Alone
  2. deaths Num Affected
    88
    deaths Num At Risk
    365
    description
    All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    EG001
    other Num Affected
    345
    other Num At Risk
    365
    serious Num Affected
    344
    serious Num At Risk
    365
    title
    RVD Plus ASCT
  3. deaths Num Affected
    1
    deaths Num At Risk
    7
    description
    RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    RVD Cycle 1 Only
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abcess
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal crampy pains
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal discomfort
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abdominal wall cyst
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal bowel sounds
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal sensation in ear
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal sensation of limbs
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abnormal vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Abrasions
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      108
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Febrile neutropenia
  3. assessment Type
    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
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      145
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Leukopenia
  5. assessment Type
    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
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      152
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      315
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Neutropenia
  8. assessment Type
    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
      357
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      302
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Acute heart failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      357
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      365
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    term
    Acute pericarditis
time Frame
Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment. Maximum treatment duration was 133.5 months in this study cohort.

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Preserved source evidence · Not medical advice