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| ID | Type | Description | Link |
|---|---|---|---|
| BRS0042 | Other Identifier | OnCore | |
| 1R01CA181659-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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PRIMARY OBJECTIVE(S):
To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.
SECONDARY OBJECTIVE(S):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Active Comparator | Control group. |
|
| Brief Behavioral Therapy for Insomnia (BBT-I) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Therapy for Insomnia (BBT-I) | Behavioral |
| ||
| Healthy Eating Education Learning (HEAL) |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Fatigue Inventory (BFI) | The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall BFI scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
adult females ≥ 21 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Oxana Palesh, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. | |
| 34357593 | Derived | Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Eating Education Learning (HEAL) | Control group. Healthy Eating Education Learning (HEAL) |
| FG001 | Brief Behavioral Therapy for Insomnia (BBT-I) | Experimental Group. Brief Behavioral Therapy for Insomnia (BBT-I) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Eating Education Learning (HEAL) | Control group. Healthy Eating Education Learning (HEAL) |
| BG001 | Brief Behavioral Therapy for Insomnia (BBT-I) | Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I) |
| 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 | Insomnia Severity Index (ISI) | The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows:
| T2 (Post intervention): 5 participants were lost to follow up & didn't complete any measures. T3 (6 months follow-up): 16 participants did not complete any measures & were lost to follow up (including 2 deceased). T4 (12 months follow-up): 14 participants did not complete any measures & were lost to follow up (including 3 deceased). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
52 months
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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 | Healthy Eating Education Learning (HEAL) | Control group. Healthy Eating Education Learning (HEAL) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease Progression | General disorders | CTCAE Version 4.03 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oxana Palesh, Associate Professor of Psychiatry and Behavioral Sciences | Stanford University | (650) 725-7011 | oxana.palesh@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2019 | Jun 9, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2015 | Jun 9, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Behavioral |
|
| 12 months |
| Clinical Assessment of Depression (CAD) | Anxiety and depression will be assessed by administration of the Clinical Assessment of Depression (CAD). The CAD questionnaire is a 50-item survey, with each statement having 4 possible responses ("Strongly Disagree" to "Strongly Agree"), scored from 1 to 4, The raw scores are then converted to T-scores. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. The CAD survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CAD scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | 12 months |
| Comprehensive Trail Making Test (CTMT) | Neuropsychological assessments will be conducted using the Comprehensive Trail Making Test (CTMT), an assessment of simple attention and executive function, consisting of 5 dot-to-dot exercises that increase with complexity and difficulty. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. Overall, higher values indicate better executive functioning, attention, and processing speed. The CTMT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CTMT scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | At baseline, post intervention, 6 months and 12 months |
| Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | Neuropsychological assessments will be conducted using the Delayed Recall sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score. A higher T scores indicating better memory (recall).A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Delayed Recall was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | At baseline, post intervention, 6 months and 12 months |
| Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | Neuropsychological assessments will be conducted using the Verbal Learning and Memory sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score.The higher T scores indicating better memory (recall). A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Verbal Learning and Memory was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | At baseline, post intervention, 6 months and 12 months |
| Controlled Oral Word Association Test (COWAT) | Neuropsychological assessments will be conducted using the Controlled Oral Word Association Test (COWAT), a verbal fluency task that assesses complex cognition. The test value is the the count of words that meet pre-defined criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Adjustments are made to the raw score based on participant age and education level, resulting in a scaled score. Higher scores reflect a better outcome, meaning better cognition and verbal fluency. The COWAT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the COWAT score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | At baseline, post intervention, 6 months and 12 months |
| Mobile Cognitive Assessment Battery (MCAB) | Cognitive difficulties will be assessed by administration of the Mobile Cognitive Assessment Battery (MCAB), comprised of 3 neuropsychological tests and a self-reported assessment. MCAB measures cognitive flexibility, accuracy, processing speed, working memory and multitasking. The MCAB survey was to be conducted at baseline, post intervention, 6 months, and 12 months. The outcome was to be reported as the mean of the overall MCAB scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | At baseline, post intervention, 6 months and 12 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 | Brief Fatigue Inventory (BFI) | The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall BFI scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | T2: 5 participants were lost to follow up & did not complete any measures. T3: 16 participants did not complete any measures & were lost to follow up (including 2 deceased). T4: 14 participants did not complete any measures & were lost to follow up (including 3 deceased). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Clinical Assessment of Depression (CAD) | Anxiety and depression will be assessed by administration of the Clinical Assessment of Depression (CAD). The CAD questionnaire is a 50-item survey, with each statement having 4 possible responses ("Strongly Disagree" to "Strongly Agree"), scored from 1 to 4, The raw scores are then converted to T-scores. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. The CAD survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CAD scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | T2(Post intervention): 6 participants were lost to follow & did not complete any measures. T3(6 months follow-up): 19 participants did not complete follow-up study visit & were lost to follow up (including 2 deceased). T4(12 months follow-up): 17 participants did not complete follow-up study visit & were lost to follow up (including 3 deceased). | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Comprehensive Trail Making Test (CTMT) | Neuropsychological assessments will be conducted using the Comprehensive Trail Making Test (CTMT), an assessment of simple attention and executive function, consisting of 5 dot-to-dot exercises that increase with complexity and difficulty. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. Overall, higher values indicate better executive functioning, attention, and processing speed. The CTMT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CTMT scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | T1(Baseline): 1 participant did not complete baseline assessment. T2(Post intervention): Total 7 participants were not analyzed; 6 participants were lost to follow up and 1 participant did not complete this measure T3(6 months follow-up): 19 participants did not complete follow-up (including 2 deceased). T4(12 months follow-up): 18 participants did not complete follow-up(including 3 deceased). | Posted | Mean | Standard Deviation | score on a scale | At baseline, post intervention, 6 months and 12 months |
|
|
|
| Secondary | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | Neuropsychological assessments will be conducted using the Delayed Recall sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score. A higher T scores indicating better memory (recall).A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Delayed Recall was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | T2 (Post intervention): 6 participants were lost to follow up & did not complete any measures. T3(6 months follow-up): 18 participants did not complete follow-up study visit (including 2 deceased). T4(12 months follow-up): 17 participants did not complete follow-up study visit (including 3 deceased). | Posted | Mean | Standard Deviation | score on a scale | At baseline, post intervention, 6 months and 12 months |
|
|
|
| Secondary | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | Neuropsychological assessments will be conducted using the Verbal Learning and Memory sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score.The higher T scores indicating better memory (recall). A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Verbal Learning and Memory was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | T2(Post intervention): 6 participants were lost to follow up & did not complete any measures. T3 (6 months follow-up): 18 participants did not complete follow-up visit (including 2 deceased). T4 (12 months follow-up): 17 participants did not complete follow-up visit (including 3 deceased). | Posted | Mean | Standard Deviation | score on a scale | At baseline, post intervention, 6 months and 12 months |
|
|
|
| Secondary | Controlled Oral Word Association Test (COWAT) | Neuropsychological assessments will be conducted using the Controlled Oral Word Association Test (COWAT), a verbal fluency task that assesses complex cognition. The test value is the the count of words that meet pre-defined criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Adjustments are made to the raw score based on participant age and education level, resulting in a scaled score. Higher scores reflect a better outcome, meaning better cognition and verbal fluency. The COWAT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the COWAT score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | T2: 6 participants were lost to follow & did not complete any measures. T3: 18 participants did not complete the 6-month follow-up study visit & were lost to follow up (including 2 deceased). T4: 17 participants did not complete the 12-month follow-up study visit & were lost to follow up (including 3 deceased). | Posted | Mean | Standard Deviation | score on a scale | At baseline, post intervention, 6 months and 12 months |
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| Secondary | Mobile Cognitive Assessment Battery (MCAB) | Cognitive difficulties will be assessed by administration of the Mobile Cognitive Assessment Battery (MCAB), comprised of 3 neuropsychological tests and a self-reported assessment. MCAB measures cognitive flexibility, accuracy, processing speed, working memory and multitasking. The MCAB survey was to be conducted at baseline, post intervention, 6 months, and 12 months. The outcome was to be reported as the mean of the overall MCAB scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. | No analysis. The MCAB analysis was determined to not be a validated measure, and the analysis was not conducted as the scores are not standardized and results do not have meaning at this time. | Posted | At baseline, post intervention, 6 months and 12 months |
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|
| 0 |
| 66 |
| 3 |
| 66 |
| 17 |
| 66 |
| EG001 | Brief Behavioral Therapy for Insomnia (BBT-I) | Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I) | 3 | 73 | 7 | 73 | 19 | 73 |
| Blood Transfusion | Blood and lymphatic system disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Flu like symptoms | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Shingles | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Skin infection | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Infection: not specified | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Allergic reaction | Immune system disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Rash Acneiform | Skin and subcutaneous tissue disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Pain | General disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Fever | General disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Nail loss | Skin and subcutaneous tissue disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Breast infection | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other, specify:Dermatomyositis | Musculoskeletal and connective tissue disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Chest pain- cardiac | Cardiac disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Gastrointestinal disorders- other, specify: Crohn's | Gastrointestinal disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Infusion related reaction: GI symptoms (unspecified) | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
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| Localized Edema | General disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Intraoperative breast injury: Breast necrosis | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| T2 (Post intervention) |
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| T3 (6 months follow-up) |
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| T4 (12 months follow-up) |
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| T2 (Post intervention) |
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| T3 (6 months follow-up) |
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| T4 (12 months follow-up) |
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| T2 (Post intervention) |
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| T3 (6 months follow-up) |
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| T4 (12 months follow-up) |
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| T2 (Post intervention) |
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| T3 (6 months follow-up) |
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| T4 (12 months follow-up) |
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| T2 (Post intervention) |
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| T3 (6 months follow-up) |
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| T4 (12 months follow-up) |
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| T2 (Post intervention) |
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| T3 (6 months follow-up) |
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| T4 (12 months follow-up) |
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