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← Malignant Uterine Corpus Neoplasm

NCT00063999 · STUDY IN CONTEXT

Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

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

The time alive in months from study entry to last contact or death.

Eligible and treated patients. Data are reported from the second interim analysis.

→

secondary · POSTED

The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).

Eligible and evaluable and enrolled prior to 3/26/2006

→

secondary · POSTED

The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.

Eligible and evaluable and enrolled prior to 3/26/2006

→

secondary · POSTED

The time alive in months from study entry to last contact or death.

Eligible patients with estrogen and progesterone receptor data.

→

secondary · POSTED

Maximum grade of physician assessed neurotoxicity and infection

Eligible and treated patients

→

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

FACT · Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-corpus-neoplasm
nct id
NCT00063999
qol key
qol-0001
source section id
NCT00063999-om-0001
source outcome index
1
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
measure definition
The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
time frame
Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible and evaluable and enrolled prior to 3/26/2006
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-corpus-neoplasm
nct id
NCT00063999
qol key
qol-0002
source section id
NCT00063999-om-0002
source outcome index
2
instrument
FACT
instrument basis
matched 'fact-g' in the study's own wording
scale title
Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
measure definition
The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
time frame
Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible and evaluable and enrolled prior to 3/26/2006
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-uterine-corpus-neoplasm
nct id
NCT00063999
trial label
Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
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
5
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0000
    source section id
    NCT00063999-om-0000
    source outcome index
    0
    endpoint
    Number of Participants Alive at Time of Last Follow-up.
    endpoint definition
    The time alive in months from study entry to last contact or death.
    time origin
    Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients. Data are reported from the second interim analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0001
    source section id
    NCT00063999-om-0001
    source outcome index
    1
    endpoint
    Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
    endpoint definition
    The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
    time origin
    Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable and enrolled prior to 3/26/2006
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0002
    source section id
    NCT00063999-om-0002
    source outcome index
    2
    endpoint
    Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
    endpoint definition
    The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
    time origin
    Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and evaluable and enrolled prior to 3/26/2006
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0003
    source section id
    NCT00063999-om-0003
    source outcome index
    3
    endpoint
    Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative)
    endpoint definition
    The time alive in months from study entry to last contact or death.
    time origin
    Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients with estrogen and progesterone receptor data.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0004
    source section id
    NCT00063999-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection
    endpoint definition
    Maximum grade of physician assessed neurotoxicity and infection
    time origin
    Assessed throughout the treatment period and for 30 days after discontinuation of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and treated patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Doxorubicin, Cisplatin, Paclitaxel)
    regimen
    Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    647
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Paclitaxel, Carboplatin)
    regimen
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    665
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Doxorubicin, Cisplatin, Paclitaxel
    regimen
    Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    228
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Paclitaxel, Carboplatin
    regimen
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    246
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Doxorubicin, Cisplatin, Paclitaxel)
    regimen
    Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    228
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Paclitaxel, Carboplatin)
    regimen
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    246
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Estrogen Receptor Positive
    regimen
    Patients with estrogen receptor positive tumors
    analyzed count
    919
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Estrogen Receptor Negative
    regimen
    Patients with estrogen receptor negative tumors
    analyzed count
    355
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Progesterone Receptor Positive
    regimen
    Patients with progesterone receptor positive tumors
    analyzed count
    832
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0003#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0003
    arm key
    OG003
    arm label
    Progesterone Receptor Negative
    regimen
    Patients with progesterone receptor negative tumors
    analyzed count
    440
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0003#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel)
    regimen
    Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    640
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm II (Paclitaxel, Carboplatin)
    regimen
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    664
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00063999-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    harm key
    EG000
    source section id
    NCT00063999-ae
    event group key
    EG000
    event group label
    Arm I (Doxorubicin, Cisplatin, Paclitaxel)
    serious affected
    217
    serious at risk
    647
    other affected
    631
    other at risk
    647
    frequency threshold
    0
    collection period
    Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years.
    event definition
    CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    harm key
    EG001
    source section id
    NCT00063999-ae
    event group key
    EG001
    event group label
    Arm II (Paclitaxel, Carboplatin)
    serious affected
    156
    serious at risk
    665
    other affected
    657
    other at risk
    665
    frequency threshold
    0
    collection period
    Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years.
    event definition
    CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    qol key
    qol-0001
    source section id
    NCT00063999-om-0001
    source outcome index
    1
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short)
    measure definition
    The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).
    time frame
    Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible and evaluable and enrolled prior to 3/26/2006
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-uterine-corpus-neoplasm
    nct id
    NCT00063999
    qol key
    qol-0002
    source section id
    NCT00063999-om-0002
    source outcome index
    2
    instrument
    FACT
    instrument basis
    matched 'fact-g' in the study's own wording
    scale title
    Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G
    measure definition
    The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.
    time frame
    Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible and evaluable and enrolled prior to 3/26/2006
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice