NCT00531284 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 65
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 7
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 10
- group Id
- BG008
- value
- 11
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 24
- units
- Participants
- groups
- description
- Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG000
- title
- P1B ST: CFZ 20 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG001
- title
- P1B ST: CFZ 20/27 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG002
- title
- P1B ST: CFZ 20/36 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG003
- title
- P2 ST: CFZ 20/36 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG004
- title
- P1B ST: CFZ 36 mg/m²
- description
- Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG005
- title
- P1B ST: CFZ 45 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG006
- title
- P1B ST: CFZ 20/45 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG007
- title
- P1B ST: CFZ 20/56 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG008
- title
- P1B ST: CFZ 20/70 mg/m²
- description
- Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG009
- title
- P1B MM: CFZ 20/36 mg/m²
- description
- Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG010
- title
- P1B MM: CFZ 20/45 mg/m²
- description
- Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG011
- title
- P1b MM: CFZ 20/56 mg/m²
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 14.74
- value
- 47.3
- group Id
- BG001
- spread
- 8.81
- value
- 60.8
- group Id
- BG002
- spread
- 11.72
- value
- 60.0
- group Id
- BG003
- spread
- 9.97
- value
- 62.0
- comment
- Not applicable for infusion arms
- group Id
- BG004
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG005
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG006
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG007
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG008
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG009
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG010
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG011
- spread
- NA
- value
- NA
- title
- Bolus Groups
- categories
- measurements
- comment
- Not applicable for bolus arms
- group Id
- BG000
- spread
- NA
- value
- NA
- comment
- Not applicable for bolus arms
- group Id
- BG001
- spread
- NA
- value
- NA
- comment
- Not applicable for bolus arms
- group Id
- BG002
- spread
- NA
- value
- NA
- comment
- Not applicable for bolus arms
- group Id
- BG003
- spread
- NA
- value
- NA
- group Id
- BG004
- spread
- 5.18
- value
- 60.0
- group Id
- BG005
- spread
- 11.10
- value
- 69.9
- group Id
- BG006
- spread
- 10.38
- value
- 61.2
- group Id
- BG007
- spread
- 7.40
- value
- 61.4
- group Id
- BG008
- spread
- 11.58
- value
- 61.6
- group Id
- BG009
- spread
- 3.77
- value
- 63.3
- group Id
- BG010
- spread
- 5.57
- value
- 72.0
- group Id
- BG011
- spread
- 9.88
- value
- 62.7
- title
- 30-minute Infusion Groups
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 38
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 7
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 27
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 7
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 17
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 27
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 8
- title
- 0
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 35
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 7
- group Id
- BG008
- value
- 7
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 15
- title
- 1
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 1
- title
- 2
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Missing
- description
- Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
- param Type
- NUMBER
- title
- Eastern Cooperative Oncology Group (ECOG) Performance Status
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 65
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 7
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 10
- group Id
- BG008
- value
- 11
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 24
- units
- Participants
- groups
- description
- Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG000
- title
- P1B ST: CFZ 20 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG001
- title
- P1B ST: CFZ 20/27 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG002
- title
- P1B ST: CFZ 20/36 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG003
- title
- P2 ST: CFZ 20/36 mg/m² Bolus
- description
- Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG004
- title
- P1B ST: CFZ 36 mg/m²
- description
- Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG005
- title
- P1B ST: CFZ 45 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG006
- title
- P1B ST: CFZ 20/45 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG007
- title
- P1B ST: CFZ 20/56 mg/m²
- description
- Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG008
- title
- P1B ST: CFZ 20/70 mg/m²
- description
- Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG009
- title
- P1B MM: CFZ 20/36 mg/m²
- description
- Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG010
- title
- P1B MM: CFZ 20/45 mg/m²
- description
- Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
- id
- BG011
- title
- P1b MM: CFZ 20/56 mg/m²
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 14.74
- value
- 47.3
- group Id
- BG001
- spread
- 8.81
- value
- 60.8
- group Id
- BG002
- spread
- 11.72
- value
- 60.0
- group Id
- BG003
- spread
- 9.97
- value
- 62.0
- comment
- Not applicable for infusion arms
- group Id
- BG004
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG005
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG006
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG007
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG008
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG009
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG010
- spread
- NA
- value
- NA
- comment
- Not applicable for infusion arms
- group Id
- BG011
- spread
- NA
- value
- NA
- title
- Bolus Groups
- categories
- measurements
- comment
- Not applicable for bolus arms
- group Id
- BG000
- spread
- NA
- value
- NA
- comment
- Not applicable for bolus arms
- group Id
- BG001
- spread
- NA
- value
- NA
- comment
- Not applicable for bolus arms
- group Id
- BG002
- spread
- NA
- value
- NA
- comment
- Not applicable for bolus arms
- group Id
- BG003
- spread
- NA
- value
- NA
- group Id
- BG004
- spread
- 5.18
- value
- 60.0
- group Id
- BG005
- spread
- 11.10
- value
- 69.9
- group Id
- BG006
- spread
- 10.38
- value
- 61.2
- group Id
- BG007
- spread
- 7.40
- value
- 61.4
- group Id
- BG008
- spread
- 11.58
- value
- 61.6
- group Id
- BG009
- spread
- 3.77
- value
- 63.3
- group Id
- BG010
- spread
- 5.57
- value
- 72.0
- group Id
- BG011
- spread
- 9.88
- value
- 62.7
- title
- 30-minute Infusion Groups
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 38
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 7
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 27
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 7
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 17
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 27
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 8
- title
- 0
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 35
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 7
- group Id
- BG008
- value
- 7
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 15
- title
- 1
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 1
- title
- 2
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Missing
- description
- Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
- param Type
- NUMBER
- title
- Eastern Cooperative Oncology Group (ECOG) Performance Status
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
Triangle