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NCT01246063 · ADVERSE EVENTS

Adverse events

Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-04-08

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
Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)

Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.

2 / 33 / 30 / 3
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)

Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.

3 / 44 / 40 / 4
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)

Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.

4 / 44 / 42 / 4
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)

Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.

3 / 55 / 50 / 5
Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)

Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.

2 / 77 / 70 / 7
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)

Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.

10 / 1717 / 171 / 17

Group identifiers: EG000: Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2) · EG001: Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2) · EG002: Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2) · EG003: Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2) · EG004: Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone) · EG005: Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)

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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Thrombotic thrombocytopenic purpura
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic valve disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Diverticulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Infusion related reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Weakness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Acute bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    RSV infection

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      17
    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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    term
    Hemolysis
  3. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Lymph node swelling
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Heart murmur
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Tricuspid valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    term
    Ear pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Right ear fullness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Tinnitus
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
  2. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
  3. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    4
    serious Num At Risk
    4
    title
    Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
  4. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
  5. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
    id
    EG004
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    Phase I -Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
  6. deaths Num Affected
    1
    deaths Num At Risk
    17
    description
    Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
    id
    EG005
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    10
    serious Num At Risk
    17
    title
    Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
frequency Threshold
0
other 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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      17
    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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    term
    Hemolysis
  3. 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
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Lymph node swelling
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Heart murmur
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Tricuspid valve disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      17
    term
    Ear pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Right ear fullness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Tinnitus
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
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Thrombotic thrombocytopenic purpura
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Aortic valve disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Diverticulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Infusion related reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      17
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Weakness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Acute bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      17
    term
    RSV infection
time Frame
Adverse events were followed from first day of study treatment until 30 days following the last day of study treatment or until the start of a new chemotherapy, whichever is sooner. Median number of cycles was 9.5 (range 1-34 cycles). All-cause mortality data was collected from first day of study treatment until completion of treatment.

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