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← Cervical Cancer

NCT00803062 · STUDY IN CONTEXT

Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical 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.

exploratory · NOT_POSTED

Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.

Source null

→

exploratory · NOT_POSTED

Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.

Source null

→

primary · POSTED

The observed length of life from randomization into the study to death or the date of last contact.

All randomized patients.

→

primary · POSTED

Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.

All randomized patients.

→

primary · POSTED

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.

All randomized patients.

→

primary · POSTED

The number of patients on each arm who have Grade 3 AE or higher toxicity.

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 · Health-related Quality of Life

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-cervical-cancer
nct id
NCT00803062
qol key
qol-0005
source section id
NCT00803062-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact-cx' in the study's own wording
scale title
Health-related Quality of Life
measure definition
Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.
time frame
Up to 9 months after course 1
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
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-cervical-cancer
nct id
NCT00803062
trial label
Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical 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
6
harms Count
4
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0004
    source section id
    NCT00803062-om-0004
    source outcome index
    4
    endpoint
    Extent of Nicotine Dependence
    endpoint definition
    Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.
    time origin
    Up to 5 years
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population 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-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0005
    source section id
    NCT00803062-om-0005
    source outcome index
    5
    endpoint
    Health-related Quality of Life
    endpoint definition
    Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.
    time origin
    Up to 9 months after course 1
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    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-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0000
    source section id
    NCT00803062-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    The observed length of life from randomization into the study to death or the date of last contact.
    time origin
    From entry into the study to death or the date of last contact, assessed up to 5 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients.
    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-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0001
    source section id
    NCT00803062-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival
    endpoint definition
    Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
    time origin
    From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients.
    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-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0002
    source section id
    NCT00803062-om-0002
    source outcome index
    2
    endpoint
    Tumor Response
    endpoint definition
    Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.
    time origin
    Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0003
    source section id
    NCT00803062-om-0003
    source outcome index
    3
    endpoint
    To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.
    endpoint definition
    The number of patients on each arm who have Grade 3 AE or higher toxicity.
    time origin
    From date of enrollment until 30 days after treatment completion
    analysis role
    primary
    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-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Paclitaxel and Cisplatin)
    regimen
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Paclitaxel, Cisplatin, Bevacizumab)
    regimen
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    115
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm III (Topotecan Hydrochloride and Paclitaxel)
    regimen
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
    analyzed count
    111
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
    regimen
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    112
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (Paclitaxel and Cisplatin)
    regimen
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Paclitaxel, Cisplatin, Bevacizumab)
    regimen
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    115
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Arm III (Topotecan Hydrochloride and Paclitaxel)
    regimen
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
    analyzed count
    111
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
    regimen
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    112
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Paclitaxel and Cisplatin)
    regimen
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Paclitaxel, Cisplatin, Bevacizumab)
    regimen
    Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    115
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Arm III (Topotecan Hydrochloride and Paclitaxel)
    regimen
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
    analyzed count
    111
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
    regimen
    Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
    analyzed count
    112
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00803062-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00803062
    harm key
    EG000
    source section id
    NCT00803062-ae
    event group key
    EG000
    event group label
    Arm I (Paclitaxel and Cisplatin)
    serious affected
    42
    serious at risk
    112
    other affected
    112
    other at risk
    112
    frequency threshold
    0
    collection period
    All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
    event definition
    Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
    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-cervical-cancer
    nct id
    NCT00803062
    harm key
    EG001
    source section id
    NCT00803062-ae
    event group key
    EG001
    event group label
    Arm II (Paclitaxel, Cisplatin, Bevacizumab)
    serious affected
    53
    serious at risk
    111
    other affected
    111
    other at risk
    111
    frequency threshold
    0
    collection period
    All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
    event definition
    Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
    undenominated note
    Source null
    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-cervical-cancer
    nct id
    NCT00803062
    harm key
    EG002
    source section id
    NCT00803062-ae
    event group key
    EG002
    event group label
    Arm III (Topotecan Hydrochloride and Paclitaxel)
    serious affected
    37
    serious at risk
    107
    other affected
    107
    other at risk
    107
    frequency threshold
    0
    collection period
    All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
    event definition
    Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
    undenominated note
    Source null
    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-cervical-cancer
    nct id
    NCT00803062
    harm key
    EG003
    source section id
    NCT00803062-ae
    event group key
    EG003
    event group label
    Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)
    serious affected
    61
    serious at risk
    109
    other affected
    107
    other at risk
    109
    frequency threshold
    0
    collection period
    All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
    event definition
    Adverse events number at risk reflects the number of patients who received treatment and submitted at least one adverse event form.
    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-cervical-cancer
    nct id
    NCT00803062
    qol key
    qol-0005
    source section id
    NCT00803062-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact-cx' in the study's own wording
    scale title
    Health-related Quality of Life
    measure definition
    Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.
    time frame
    Up to 9 months after course 1
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    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