NCT00531284 · STUDY IN CONTEXT

Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding. The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which \< 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle.

Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.

→

primary · POSTED

Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target and non-target lesions and no new lesions; PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions.

Phase 2 Safety population

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secondary · POSTED

Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM. Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.

Safety Population

→

secondary · POSTED

Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.

Safety Population with a partial response or better

→

secondary · POSTED

Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.

Safety population

→

secondary · POSTED

Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.

Safety population.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-ovarian-neoplasm
nct id: NCT00531284
trial label: Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 17
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
source section id
NCT00531284-om-0000
source outcome index
0
endpoint
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)
endpoint definition
Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding. The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which \< 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle.
time origin
28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0001
source section id
NCT00531284-om-0001
source outcome index
1
endpoint
Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles
endpoint definition
Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target and non-target lesions and no new lesions; PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions.
time origin
4 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Phase 2 Safety population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0002
source section id
NCT00531284-om-0002
source outcome index
2
endpoint
Percentage of Participants With an Overall Response Throughout the Study
endpoint definition
Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM. Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR.
time origin
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0003
source section id
NCT00531284-om-0003
source outcome index
3
endpoint
Duration of Response
endpoint definition
Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.
time origin
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety Population with a partial response or better
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0004
source section id
NCT00531284-om-0004
source outcome index
4
endpoint
Progression-Free Survival
endpoint definition
Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.
time origin
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0005
source section id
NCT00531284-om-0005
source outcome index
5
endpoint
Time to Progression
endpoint definition
Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.
time origin
Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG000
arm label
P1B ST: CFZ 20 mg/m² Bolus
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG001
arm label
P1B ST: CFZ 20/27 mg/m² Bolus
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG002
arm label
P1B ST: CFZ 20/36 mg/m² Bolus
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG003
arm label
P1B ST: CFZ 36 mg/m²
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG004
arm label
P1B ST: CFZ 45 mg/m²
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG005
arm label
P1B ST: CFZ 20/45 mg/m²
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG006
arm label
P1B ST: CFZ 20/56 mg/m²
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG007
arm label
P1B ST: CFZ 20/70 mg/m²
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG008
arm label
P1B MM: CFZ 20/36 mg/m²
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG009
arm label
P1B MM: CFZ 20/45 mg/m²
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG010
arm label
P1b MM: CFZ 20/56 mg/m²
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
outcome key
om-0000
arm key
OG011
arm label
P1B MM: CFZ 20/70 mg/m²
regimen
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 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.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00531284-om-0000#groups/OG011

harms

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG000
source section id
NCT00531284-ae
event group key
EG000
event group label
P1B ST: CFZ 20 mg/m² Bolus
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG001
source section id
NCT00531284-ae
event group key
EG001
event group label
P1B ST: CFZ 20/27 mg/m² Bolus
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG002
source section id
NCT00531284-ae
event group key
EG002
event group label
P1B ST: CFZ 20/36 mg/m² Bolus
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG003
source section id
NCT00531284-ae
event group key
EG003
event group label
P2 ST: CFZ 20/36 mg/m² Bolus
serious affected
27
serious at risk
65
other affected
65
other at risk
65
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG004
source section id
NCT00531284-ae
event group key
EG004
event group label
P1B ST: CFZ 36 mg/m²
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG005
source section id
NCT00531284-ae
event group key
EG005
event group label
P1B ST: CFZ 45 mg/m²
serious affected
4
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG006
source section id
NCT00531284-ae
event group key
EG006
event group label
P1B ST: CFZ 20/45 mg/m²
serious affected
5
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG007
source section id
NCT00531284-ae
event group key
EG007
event group label
P1B ST: CFZ 20/56 mg/m²
serious affected
5
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG008
source section id
NCT00531284-ae
event group key
EG008
event group label
P1B ST: CFZ 20/70 mg/m²
serious affected
6
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG009
source section id
NCT00531284-ae
event group key
EG009
event group label
P1B MM: CFZ 20/36 mg/m²
serious affected
2
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG010
source section id
NCT00531284-ae
event group key
EG010
event group label
P1B MM: CFZ 20/45 mg/m²
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm
nct id
NCT00531284
harm key
EG011
source section id
NCT00531284-ae
event group key
EG011
event group label
P1B MM: CFZ 20/56 mg/m²
serious affected
11
serious at risk
24
other affected
24
other at risk
24
frequency threshold
5
collection period
From the first administration of carfilzomib and within 30 days after the last dose of study treatment; maximum duration of treatment was 366 days for bolus administration and 1073 days for infusion
event definition
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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Preserved source evidence · Not medical advice