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Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.
This randomized clinical trial will assess the efficacy of using physical activity behavior change intervention for Veterans recovering from total knee arthroplasty. Testing will occur at baseline (before surgery), at intervention midpoint (8 weeks after surgery), end of intervention (14 weeks after surgery), and 24 weeks after intervention. The primary outcome is accelerometer-assessed daily step count. Secondary outcomes include the percent time engaged in standing and walking activity and physical function (Six-Minute Walk, 30-Second Chair-Stand Test, Timed Up-and-Go, Western Ontario and McMaster Universities Osteoarthritis Index, and the Veterans RAND 12-Item Health Survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Behavior Intervention | Experimental | A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement. |
|
| Attention Control | Active Comparator | Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Behavior Intervention | Behavioral | Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning. |
| Measure | Description | Time Frame |
|---|---|---|
| Free-living Daily Step Count | Accelerometer-based measurement of free-living daily step count | End of intervention (14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Second Chair-Stand Test W14 | Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds. | End of intervention (14 weeks) |
| 30-Second Chair-Stand Test W38 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cory L. Christiansen, PhD | Rocky Mountain Regional VA Medical Center, Aurora, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30329126 | Background | Kline PW, Melanson EL, Sullivan WJ, Blatchford PJ, Miller MJ, Stevens-Lapsley JE, Christiansen CL. Improving Physical Activity Through Adjunct Telerehabilitation Following Total Knee Arthroplasty: Randomized Controlled Trial Protocol. Phys Ther. 2019 Jan 1;99(1):37-45. doi: 10.1093/ptj/pzy119. | |
| 37819260 | Background |
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Participant data will be made available at time of study completion, per VA recommendations and approval.
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114 participants were enrolled in the study. There were n=22 participants lost to follow-up before randomization: n=14 post-consent screen fail, n=7 withdrew, and n=1 no valid baseline activity data. n=92 participants were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity Behavior Intervention | A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement. Physical Activity Behavior Intervention: Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning. |
| FG001 | Attention Control | Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
US military Veterans (aged 50-85 years) scheduled for unilateral TKA.
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity Behavior Intervention | A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement. Physical Activity Behavior Intervention: Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Free-living Daily Step Count | Accelerometer-based measurement of free-living daily step count | Posted | Mean | Inter-Quartile Range | step count | End of intervention (14 weeks) |
|
Adverse events were collected between baseline testing (pre-surgery) through the end of the study at 38 weeks post-surgery.
Adverse events were collected throughout the study and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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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 | Physical Activity Behavior Intervention | A 12-week behavior change intervention that supplements conventional rehabilitation including: 10 telerehabilitation sessions, daily activity sensor use, education, self-monitoring, tailored feedback, barrier/facilitator identification, promotion of problem solving, action planning, and encouragement. Physical Activity Behavior Intervention: Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cory Christiansen, PT, PhD | Eastern Colorado VA Medical Center | 303-724-9101 | cory.christiansen@cuanschutz.edu |
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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 18, 2021 | Oct 11, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2020 | Sep 6, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Randomized controlled trial; Two groups.
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|
| Attention Control | Other | Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. |
|
Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds.
| 24 weeks after intervention (week 38 of study) |
| Six-Minute Walk Test W14 | Physical function test measuring the total distance walked in a span of six minutes. | End of intervention (14 weeks) |
| Six-Minute Walk Test W38 | Physical function test measuring the total distance walked in a span of six minutes. | 24 weeks after intervention (week 38 of study) |
| Timed Up-and-Go Test W14 | A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting. | End of intervention (14 weeks) |
| Timed Up-and-Go Test W38 | A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting. | 24 weeks after intervention (week 38 of study) |
| Western Ontario and McMaster Universities Osteoarthritis Index W14 | Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points. | End of intervention (14 weeks) |
| Western Ontario and McMaster Universities Osteoarthritis Index W38 | Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points. | 24 weeks after intervention (week 38 of the study) |
| Veterans RAND 12-Item Health Survey Physical Component W14 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | End of intervention (14 weeks) |
| Veterans RAND 12-Item Health Survey Physical Component W38 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | 24 weeks after intervention (week 38 of study) |
| Veterans RAND 12-Item Health Survey Mental Component W14 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | End of intervention (14 weeks) |
| Veterans RAND 12-Item Health Survey Mental Component W38 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | 24 weeks after intervention (week 38 of study) |
| Free-living Daily Step Count W38 | Accelerometer-based measurement of free-living daily step count | 24 weeks after intervention (week 38 of study) |
| Hoffman RM, Davis-Wilson HC, Hanlon S, Swink LA, Kline PW, Juarez-Colunga E, Melanson EL, Christiansen CL. Maximal daily stepping cadence partially explains functional capacity of individuals with end-stage knee osteoarthritis. PM R. 2024 Jun;16(6):532-542. doi: 10.1002/pmrj.13082. Epub 2023 Nov 27. |
| 40776781 | Derived | Hanlon SL, Miller MJ, Swink LA, Hoffman RM, Kline PW, Christiansen CL. Preoperative physical health and psychosocial characteristics influence postoperative mobility in veterans following total knee arthroplasty: A structural equation modeling approach. PM R. 2026 Mar;18(3):305-314. doi: 10.1002/pmrj.13439. Epub 2025 Aug 8. |
| 39001713 | Derived | Christiansen CL, Kline PW, Anderson CB, Melanson EL, Sullivan WJ, Richardson VL, Juarez-Colunga E, Stevens-Lapsley JE. Optimizing Total Knee Arthroplasty Rehabilitation With Telehealth Physical Activity Behavior Change Intervention: A Randomized Clinical Trial. Phys Ther. 2024 Oct 2;104(10):pzae088. doi: 10.1093/ptj/pzae088. |
| Lost to Follow-up |
|
| BG001 | Attention Control | Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| OG001 | Attention Control | Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. |
|
|
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| Secondary | 30-Second Chair-Stand Test W14 | Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds. | Posted | Mean | Inter-Quartile Range | sit-stand-sit transitions | End of intervention (14 weeks) |
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|
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| Secondary | 30-Second Chair-Stand Test W38 | Physical function test that assesses the number of sit-stand-sit transitions that a participant performs in the span of 30 seconds. | Posted | Mean | Inter-Quartile Range | sit-stand-sit transitions | 24 weeks after intervention (week 38 of study) |
|
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|
|
| Secondary | Six-Minute Walk Test W14 | Physical function test measuring the total distance walked in a span of six minutes. | Posted | Mean | Inter-Quartile Range | meters | End of intervention (14 weeks) |
|
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| Secondary | Six-Minute Walk Test W38 | Physical function test measuring the total distance walked in a span of six minutes. | Posted | Mean | Inter-Quartile Range | meters | 24 weeks after intervention (week 38 of study) |
|
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|
| Secondary | Timed Up-and-Go Test W14 | A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting. | Posted | Mean | Inter-Quartile Range | seconds | End of intervention (14 weeks) |
|
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| Secondary | Timed Up-and-Go Test W38 | A physical performance measure that includes rising from a chair, walking 3 meters, turning 180 degrees, returning to chair, and sitting. | Posted | Mean | Inter-Quartile Range | seconds | 24 weeks after intervention (week 38 of study) |
|
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|
|
| Secondary | Western Ontario and McMaster Universities Osteoarthritis Index W14 | Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points. | Posted | Mean | Inter-Quartile Range | score on a scale | End of intervention (14 weeks) |
|
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|
|
| Secondary | Western Ontario and McMaster Universities Osteoarthritis Index W38 | Self-report health status measure of pain, stiffness, and function for people with osteoarthritis of the hip or knee. A higher score indicates worse outcome with the Total Score range from 0-96. A positive change indicates worse outcome and a negative change indicates a better outcome across time points. | Posted | Mean | Inter-Quartile Range | score on a scale | 24 weeks after intervention (week 38 of the study) |
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| Secondary | Veterans RAND 12-Item Health Survey Physical Component W14 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | Posted | Mean | Inter-Quartile Range | Percentage of total | End of intervention (14 weeks) |
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| Secondary | Veterans RAND 12-Item Health Survey Physical Component W38 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | Posted | Mean | Inter-Quartile Range | Percentage of total | 24 weeks after intervention (week 38 of study) |
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| Secondary | Veterans RAND 12-Item Health Survey Mental Component W14 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | Posted | Mean | Inter-Quartile Range | Percentage of total | End of intervention (14 weeks) |
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| Secondary | Veterans RAND 12-Item Health Survey Mental Component W38 | A self-report assessment of health-related quality of life assessing the domains of physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. | Posted | Mean | Inter-Quartile Range | Percentage of total | 24 weeks after intervention (week 38 of study) |
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| Secondary | Free-living Daily Step Count W38 | Accelerometer-based measurement of free-living daily step count | Posted | Mean | Inter-Quartile Range | step count | 24 weeks after intervention (week 38 of study) |
|
|
|
|
| 0 |
| 46 |
| 3 |
| 46 |
| 33 |
| 46 |
| EG001 | Attention Control | Conventional rehabilitation with 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. Attention Control: Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions. | 0 | 46 | 8 | 46 | 43 | 46 |
| Gastrointestinal Disorders | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Musculoskeletal & connective tissue disorders | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
| Eye disorders | Eye disorders | CTCAE (5.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Immune system disorders | Immune system disorders | CTCAE (5.0) | Systematic Assessment |
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| Infections and infestations | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Musculoskeletal & connective tissue disorders | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Vascular disorder | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D001519 |
| Behavior |