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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03244 | Registry Identifier | NCI / CTRP | |
| 8771 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Study closed to accrual early due to side effects of study drug.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This phase I/II trial studies whether glasdegib is helpful in treating sclerosis associated with chronic graft-versus-host disease. It will also investigate the safety of glasdegib in treating patients with chronic graft-versus-host disease.
OUTLINE: This is a phase I/II study.
Patients receive glasdegib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (glasdegib) | Experimental | Patients receive glasdegib PO QD on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glasdegib | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | Safety assessments will consist of monitoring and recording adverse events. | From the start of treatment through 28 days after stopping study drug (Up to 25 months total) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) in Sclerotic Manifestations | ORR will be calculated according to (1) the response definitions of the National Institute of Health (NIH) Consensus Conference for (a) skin or joint scores (0-3), where improvement by at least 1 point is a partial response (PR) and return to score 0 is a complete response (CR), or (b) the photographic range of motion scale (0-25) where improvement by at least 1 point is a PR and return to score 25 is a CR; and (2) change in the 0-10 sclerotic severity scale where at least a 2 point improvement is a PR or return to 0 (CR). Non-responders are those with mixed response (improvement in one regard and worsening in another), unchanged (stable), and progression. |
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Inclusion Criteria:
Diagnosed with moderate or severe cGVHD according to the 2014 National Institute of Health (NIH) Consensus Criteria
Diagnosed with cGVHD-related sclerosis or fasciitis
New, stable or progressive sclerosis/fasciitis despite treatment with at least one prior line of systemic therapy for cGVHD
Female patients who:
Male patients who:
Absolute neutrophil count (ANC) > 1000/uL
Platelet count > 50 x 10^9/mL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x upper limit of normal (ULN) unless attributed to cGVHD
Normal total bilirubin unless attributed to cGVHD
Creatinine < 2.0 mg/dl
Exclusion Criteria:
Hospitalization for evaluation or management of an infection within the last 8 weeks
Known organ dysfunction
Addition of any new systemic immunosuppressive treatment within the last 2 weeks
* Addition of new systemic immunosuppressive treatment along with glasdegib is also prohibited
Corrected QT (QTc) interval > 480 ms
Female patients who are lactating or have a positive serum pregnancy test
Major surgery within 14 days before enrollment
* Does not include placement of venous access device, bone marrow biopsy, GVHD diagnostic biopsy, or other routine procedures in chronic GVHD or post-transplantation care
Use of any concomitant medications meds that are prohibited within the past 7 days
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
Known intolerance to glasdegib, sonidegib, or vismodegib
Non-hematologic malignancy within the past 2 years with the exception of:
Treatment with non-Food and Drug Administration (FDA) approved drug within 21 days of start of this trial
Evidence of recurrent or progressive underlying malignant disease
Karnofsky performance status < 70%
History of non-compliance
Life expectancy < 6 months
Grade 2 or 3 muscle cramping, or grade 1 muscle cramping that occurs at least weekly
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Lee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Huntsman Cancer Institute/University of Utah |
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After the participant signed and dated the Informed Consent Form (ICF), screening began. Once all screening procedures were completed and eligibility was confirmed, the participant was enrolled into the study. The screening period lasted from the date the participant signed consent until they completed the enrollment visit and started study drug.
Potentially eligible patients were approached at participating study centers during clinic visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Glasdegib) | Patients receive glasdegib PO QD on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Glasdegib: Given PO |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Glasdegib) | Patients receive glasdegib PO QD on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Glasdegib: Given PO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced an Adverse Event | Safety assessments will consist of monitoring and recording adverse events. | Posted | Count of Participants | Participants | From the start of treatment through 28 days after stopping study drug (Up to 25 months total) |
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The AE reporting period for this study began when the participant received their first dose of study drug and ended with the EOT visit, or 28 days after the last dose of study drug, whichever was later. Exceptions to this reporting period were (a) any AE occurring due to a protocol-specific screening procedure; and (b) any SAE occuring beyond 28 days after the last dose of glasdegib AND assessed by the investigator as possibly related to glasdegib.
The study collected Grade 3 and above adverse events, with these exceptions:
An abnormal lab value; unless it led to discontinuation, delay, or modification in treatment, therapeutic intervention, the investigator considered it to be clinically significant, or it met seriousness criteria.
Chronic GVHD manifestations were not collected as AE's unless they meet seriousness criteria.
Hospitalization for elective treatment of a stable pre-existing condition was not considered an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Glasdegib) | Patients receive glasdegib PO QD on days 1-28. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Glasdegib: Given PO |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute myopathy | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment | progressive generalized muscle weakness of unclear etiology, most consistent with acute myopathy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| muscle cramping | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
Early termination led to a smaller than planned number of participants. Several participants met a study-defined endpoint (e.g. starting a new systemic GVHD therapy) or withdrew from the study after stopping study drug, limiting our ability to assess patient-reported outcomes over the long term.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Lee | Fred Hutchinson Cancer Center | 206-667-6190 | sjlee@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2023 | Apr 16, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2022 | Apr 4, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D005208 | Fasciitis |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| C000592580 | glasdegib |
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| Up to 12 months after starting glasdegib |
| ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations | ORR will be calculated according to the response definitions of the NIH Consensus Conference. | Up to 12 months after the starting glasdegib |
| Failure-free Survival | Failure-free survival will be estimated using the Kaplan-Meier method (product limit estimator), with death, relapse, or start of another systemic immunosuppressive agent considered as events. Patients lost to follow-up or who withdraw consent will be censored. | At 12 months |
| Symptom Burden Assessment - Absolute Change | Subjects will provide assessments of their symptom burden using a validated instrument recommended by the NIH Consensus on Chronic GVHD (Lee Chronic GVHD Symptom Scale). These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Summary scores will be calculated based on published algorithms with absolute changes from baseline and clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. Lee Symptom Scale: minimum 0, maximum 100; higher score is worse outcome. Due to lack of adequate data at cycles 7 and 10, only Cycle 4 and End of Treatment are presented | Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253), they are not presented.] |
| Quality of Life Assessment | Subjects will provide assessments of their quality of life using the NIH-endorsed Patient Reported Outcomes Measurement Information System (PROMIS)-29. These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Scores will be calculated based on published algorithms with absolute changes from baseline for the population as a whole and based on CR+PR versus stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. PROMIS-29 theoretical minimums and maximums are as follows: Physical Function: 22.5-57.0 Depression: 41.0-79.4 Anxiety: 40.3-81.6 Sleep Disturbance: 32.0-73.3 Fatigue: 33.7-75.8 Ability to Participate in Social Roles: 27.5-64.2 Pain Interference: 41.6-75.6 Higher score means a better outcome for Physical Function, Sleep Disturbance, and Social Roles. Higher score means a worse outcome for Anxiety, Depression, Fatigue, and Pain Interference. | Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253) they are not presented.] |
| Biologic Impact of Hedgehog Pathway Inhibition | Banking of blood and skin biopsy material for future biologic studies of hedgehog pathway inhibition. | Up to 12 months |
| Symptom Burden Assessment - Clinically Meaningful Change | Subjects will provide assessments of their symptom burden using a validated instrument recommended by the NIH Consensus on Chronic GVHD (Lee Chronic GVHD Symptom Scale). These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Summary scores will be calculated based on published algorithms with absolute changes from baseline and clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. Lee Symptom Scale: minimum 0, maximum 100; higher score is worse outcome. Due to lack of adequate data at cycles 7 and 10, only Cycle 4 and End of Treatment are presented | Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253), they are not presented.] |
| Quality of Life Assessment - Clinically Meaningful Change | Subjects will provide assessments of their quality of life using the NIH-endorsed Patient Reported Outcomes Measurement Information System (PROMIS)-29. These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Scores for physical functioning will be calculated based on published algorithms with clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. PROMIS-29 minimums and maximums as follows: Physical Function: 22.5-57.0 Depression: 41.0-79.4 Anxiety: 40.3-81.6 Sleep Disturbance: 32.0-73.3 Fatigue: 33.7-75.8 Ability to Participate in Social Roles: 27.5-64.2 Pain Interference: 41.6-75.6 Higher score means a better outcome for Physical Function, Sleep, and Social Roles. Higher score means a worse outcome for Anxiety, Depression, Fatigue, and Pain. | Cycle 4 (Day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253) they are not presented.] |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Overall Response Rate (ORR) in Sclerotic Manifestations | ORR will be calculated according to (1) the response definitions of the National Institute of Health (NIH) Consensus Conference for (a) skin or joint scores (0-3), where improvement by at least 1 point is a partial response (PR) and return to score 0 is a complete response (CR), or (b) the photographic range of motion scale (0-25) where improvement by at least 1 point is a PR and return to score 25 is a CR; and (2) change in the 0-10 sclerotic severity scale where at least a 2 point improvement is a PR or return to 0 (CR). Non-responders are those with mixed response (improvement in one regard and worsening in another), unchanged (stable), and progression. | Posted | Count of Participants | Participants | Up to 12 months after starting glasdegib |
|
|
|
| Secondary | ORR in All Chronic Graft Versus Host Disease (cGVHD) Manifestations | ORR will be calculated according to the response definitions of the NIH Consensus Conference. | Posted | Count of Participants | Participants | Up to 12 months after the starting glasdegib |
|
|
|
| Secondary | Failure-free Survival | Failure-free survival will be estimated using the Kaplan-Meier method (product limit estimator), with death, relapse, or start of another systemic immunosuppressive agent considered as events. Patients lost to follow-up or who withdraw consent will be censored. | Five patients censored because they left the study before month 12 | Posted | Number | 95% Confidence Interval | percentage | At 12 months |
|
|
|
| Secondary | Symptom Burden Assessment - Absolute Change | Subjects will provide assessments of their symptom burden using a validated instrument recommended by the NIH Consensus on Chronic GVHD (Lee Chronic GVHD Symptom Scale). These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Summary scores will be calculated based on published algorithms with absolute changes from baseline and clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. Lee Symptom Scale: minimum 0, maximum 100; higher score is worse outcome. Due to lack of adequate data at cycles 7 and 10, only Cycle 4 and End of Treatment are presented | Data not available for 5 and 4 participants for the Cycle 4 and End of Treatment visits, respectively. | Posted | Mean | Standard Deviation | score on a scale | Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253), they are not presented.] |
|
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|
| Secondary | Quality of Life Assessment | Subjects will provide assessments of their quality of life using the NIH-endorsed Patient Reported Outcomes Measurement Information System (PROMIS)-29. These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Scores will be calculated based on published algorithms with absolute changes from baseline for the population as a whole and based on CR+PR versus stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. PROMIS-29 theoretical minimums and maximums are as follows: Physical Function: 22.5-57.0 Depression: 41.0-79.4 Anxiety: 40.3-81.6 Sleep Disturbance: 32.0-73.3 Fatigue: 33.7-75.8 Ability to Participate in Social Roles: 27.5-64.2 Pain Interference: 41.6-75.6 Higher score means a better outcome for Physical Function, Sleep Disturbance, and Social Roles. Higher score means a worse outcome for Anxiety, Depression, Fatigue, and Pain Interference. | Data not available for 5 participants at Cycle 4 and 4 participants for End of Treatment (EOT) | Posted | Mean | Standard Error | score on a scale | Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253) they are not presented.] |
|
|
|
| Secondary | Biologic Impact of Hedgehog Pathway Inhibition | Banking of blood and skin biopsy material for future biologic studies of hedgehog pathway inhibition. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
| Secondary | Symptom Burden Assessment - Clinically Meaningful Change | Subjects will provide assessments of their symptom burden using a validated instrument recommended by the NIH Consensus on Chronic GVHD (Lee Chronic GVHD Symptom Scale). These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Summary scores will be calculated based on published algorithms with absolute changes from baseline and clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. Lee Symptom Scale: minimum 0, maximum 100; higher score is worse outcome. Due to lack of adequate data at cycles 7 and 10, only Cycle 4 and End of Treatment are presented | Data not available for 5 and 4 participants at the Cycle 4 and End of Treatment (EOT) visits, respectively. | Posted | Count of Participants | Participants | Cycle 4 (day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253), they are not presented.] |
|
|
|
| Secondary | Quality of Life Assessment - Clinically Meaningful Change | Subjects will provide assessments of their quality of life using the NIH-endorsed Patient Reported Outcomes Measurement Information System (PROMIS)-29. These will be collected before starting glasdegib on day 1 of cycle 1, and again on day (D)1, cycles 4, 7, 10 and end of treatment. Scores for physical functioning will be calculated based on published algorithms with clinically meaningful changes described for the population as a whole and based on CR+PR versus (vs.) stable disease (SD)+mixed response (MR)+progressive disease (PD), when adequate data are available for analysis. PROMIS-29 minimums and maximums as follows: Physical Function: 22.5-57.0 Depression: 41.0-79.4 Anxiety: 40.3-81.6 Sleep Disturbance: 32.0-73.3 Fatigue: 33.7-75.8 Ability to Participate in Social Roles: 27.5-64.2 Pain Interference: 41.6-75.6 Higher score means a better outcome for Physical Function, Sleep, and Social Roles. Higher score means a worse outcome for Anxiety, Depression, Fatigue, and Pain. | Data not available for 5 and 4 participants at the Cycle 4 and End of Treatment (EOT) visits, respectively. | Posted | Count of Participants | Participants | Cycle 4 (Day 85) and End of Treatment (up through 24 months) [Due to lack of adequate data at cycles 7 (day 169) and 10 (day 253) they are not presented.] |
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| 2 |
| 15 |
| 3 |
| 15 |
| 9 |
| 15 |
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| upper respiratory infection | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment | symptoms suggestive of a URI, increased oxygen needs, no infectious agent identified |
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| mastitis | Infections and infestations | CTCAE (Unspecified) | Non-systematic Assessment | infected breast wound of unclear etiology |
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| hyponatremia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| hypokalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| myalgia | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D009140 | Musculoskeletal Diseases |
| Progressive |
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| progressive |
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| ORR for sclerotic manifestations |
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| End of Treatment |
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| Cycle 4 (day 85) - Anxiety absolute change |
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| Cycle 4 (day 85) - Depression absolute change |
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| Cycle 4 (day 85) - Fatigue absolute change |
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| Cycle 4 (day 85) - Sleep Disturbance absolute change |
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| Cycle 4 (day 85) - Ability to Participate in Social Roles absolute change |
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| Cycle 4 (day 85) - Pain Interference absolute change |
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| End of Treatment - Physical Function absolute change |
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| End of Treatment - Anxiety absolute change |
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| End of Treatment - Depression absolute change |
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| End of Treatment - Fatigue absolute change |
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| End of Treatment - Sleep Disturbance absolute change |
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| End of Treatment - Ability to Participate in Social Roles absolute change |
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| End of Treatment - Pain Interference absolute change |
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| No change |
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| Worse |
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| End of Treatment |
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| No change |
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| Worse |
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| Cycle 4 (Day 85) - Anxiety clinically meaningful change |
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| Cycle 4 (Day 85)- Depression clinically meaningful change |
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| Cycle 4 (Day 85)- Fatigue clinically meaningful change |
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| Cycle 4 (Day 85) - Sleep Disturbance clinically meaningful change |
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| Cycle 4 (Day 85) - Ability to Participate in Social Roles clinically meaningful change |
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| Cycle 4 (Day 85) - Pain Interference clinically meaningful change |
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| End of Treatment - Physical Function clinically meaningful change |
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| End of Treatment - Anxiety clinically meaningful change |
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| End of Treatment - Depression clinically meaningful change |
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| End of Treatment - Fatigue clinically meaningful change |
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| End of Treatment - Sleep Disturbance clinically meaningful change |
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| End of Treatment - Ability to Participate in Social Roles clinically meaningful change |
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| End of Treatment - Pain Interference clinically meaningful change |
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