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The primary purpose of the clinical study is to determine the safety of a modified stem cell SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke patients must be between 6 and 60 months after their stroke, and with only this one prior stroke, and with no further improvement from physical therapy.
Chronic, stable stroke patients have no existing alternative treatments after rehabilitation therapy. SB623, a modified stem cell preparation, has been shown to improve motor function when administered in animal models of stable stroke. Safety studies in animals have shown no adverse events attributed to SB623. Patients who meet the entry criteria for this study will have regular examinations, radiological evaluations (CT, MRI, PET), and be followed for two years. Regular neurological evaluations will also be done using standard questionnaires, with occasional video recording if improvements are evident. Key entry criteria for this study, in addition to 6-60 months post-ischemic stroke, include moderately severe symptoms--e.g., difficulty standing or walking, and/or difficulty using arms or hands, and/or speech impediments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB623 Implant (2.5M) | Experimental | 2.5 million SB623 cells |
|
| SB623 Implant (5.0M) | Experimental | 5 million SB623 cells |
|
| SB623 Implant (10.0M) | Experimental | 10 million SB623 cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB623 | Biological | SB623, a modified stem-cell product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs) | Number of subjects with TEAEs by maximum severity. The severity of all AEs was assessed by the Investigator using the World Health Organization (WHO) Toxicity Scale. For abnormalities not found elsewhere in the WHO table, the following scale was used to assign severity: Mild: Transient mild discomfort; no limitation in activity; no medical intervention/therapy required. Moderate: Mild-to-moderate limitation in activity; some assistance may be need. No or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required; hospitalization or prolongation of current hospitalization possible. Life-threatening: Extreme limitation in activity, significant assistance required; significant medial intervention/therapy required; hospitalization or prolongation of current hospitalization or hospice care probable. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the European Stroke Scale (ESS) Total Score From Baseline at Month 6 | The ESS is the sum of 14 items that are used to assess a patient who has recently had a stroke. These 14 items are level of consciousness, comprehension, speech, visual field, gaze, facial movement, arm in outstretched position, arm raising, extension of the wrist, fingers, leg maintained in position, leg flexing, dorsiflexion of the foot, and gait. A certain number of points are given for each parameter. The range of the total score of ESS is 0 - 100, with a completely normal person having a score of 100 and maximally affected person with a score of zero. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary K Steinberg, M.D., Ph.D. | Stanford University | Principal Investigator |
| Lawrence R Wechsler, M.D. | University of Pittsburgh Medical Center | Principal Investigator |
| Joshua M Rosenow, M.D.,FACS | Northwestern University | Principal Investigator |
| James Markert, M.D. | University of Alabama at Birmingham | Principal Investigator |
| Robert E Gross, M.D., Ph.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-3410 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30497166 | Derived | Steinberg GK, Kondziolka D, Wechsler LR, Lunsford LD, Kim AS, Johnson JN, Bates D, Poggio G, Case C, McGrogan M, Yankee EW, Schwartz NE. Two-year safety and clinical outcomes in chronic ischemic stroke patients after implantation of modified bone marrow-derived mesenchymal stem cells (SB623): a phase 1/2a study. J Neurosurg. 2018 Nov 23;131(5):1462-1472. doi: 10.3171/2018.5.JNS173147. Print 2019 Nov 1. | |
| 27256670 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SB623 Implant (2.5M) | 2.5 million SB623 cells SB623: SB623, a modified stem-cell product |
| FG001 | SB623 Implant (5.0M) | 5 million SB623 cells SB623: SB623, a modified stem-cell product |
| FG002 | SB623 Implant (10.0M) | 10 million SB623 cells SB623: SB623, a modified stem-cell product |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SB623 Implant (2.5M) | 2.5 million SB623 cells SB623: SB623, a modified stem-cell product |
| BG001 | SB623 Implant (5.0M) | 5 million SB623 cells SB623: SB623, a modified stem-cell product |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Subjects With Treatment Emergent Adverse Events (TEAEs) | Number of subjects with TEAEs by maximum severity. The severity of all AEs was assessed by the Investigator using the World Health Organization (WHO) Toxicity Scale. For abnormalities not found elsewhere in the WHO table, the following scale was used to assign severity: Mild: Transient mild discomfort; no limitation in activity; no medical intervention/therapy required. Moderate: Mild-to-moderate limitation in activity; some assistance may be need. No or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required; hospitalization or prolongation of current hospitalization possible. Life-threatening: Extreme limitation in activity, significant assistance required; significant medial intervention/therapy required; hospitalization or prolongation of current hospitalization or hospice care probable. | Safety population includes all enrolled patients who have received study treatment and who have any post-baseline data. | Posted | Count of Participants | Participants | 6 months |
|
6 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 | SB623 Implant (2.5M) | 2.5 million SB623 cells SB623: SB623, a modified stem-cell product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carotid artery stenosis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bijan Nejadnik M.D.; Chief Medical Officer | SanBio, Inc. | 650-625-2205 | Bijan.Nejadnik@sanbio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 11, 2014 | Aug 1, 2022 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2016 | Jun 3, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 6 months |
| Change in the European Stroke Scale (ESS) Motor Function Total Score From Baseline at Month 6 | The ESS motor function score is a sum of the selected items: facial movement, arm in outstretched position, arm raising, extension of wrist, fingers, leg maintained in position, leg flexing, dorsiflexion of foot, and gait. A completely normal person will have a score of 66. The maximally affected person will have a score of zero. | 6 months |
| Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score From Baseline at Month 6 | The NIHSS is a standardized method used to measure the level of impairment caused by a stroke. The scale consists of 11 items that measure several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. A certain number of points are given for each impairment uncovered during a focused neurological examination. A maximal score of 42 represents the most severe and devastating stroke with 0=no stroke, 1-4=minor stroke, 5-15=moderate stroke, 15-20=moderate/severe stroke, and 21-42=severe stroke. | 6 months |
| Change in the National Institutes of Health Stroke Scale (NIHSS) Motor Function Total Score From Baseline at Month 6 | The NIHSS is a standardized method used to measure the level of impairment caused by a stroke. The NIHSS Motor Function Total Score consists of 3 items: motor arm, motor leg, and limb ataxia, with 0 = no stroke and a maximal score of 18 = most severe impairment for motor function. | 6 months |
| Change in the Modified Rankin Scale (mRS) Response From Baseline at Month 6 | The mRS is a commonly used scale for measuring the degree of disability in daily activities for patients who have suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death. | 6 months |
| Change in the Fugl-Meyer Total Score From Baseline at Month 6 | The Fugl-Meyer Scale is a stroke-specific, performance-based impairment index. The scale is comprised of 5 domains (motor score, sensation, balance, joint range of motion, and joint pain) with 155 items in total. Scoring is based on direct observation of performance. Scale items in all 5 domains are scored on the basis of ability to complete the item using a 3-point Likert-type ordinal scale, where 0=cannot perform, 1=performs partially, and 2=performs fully. Points are divided among the domains: (a) Motor performance [0 (hemiplegia) - 100 (normal motor performance) points]; (b) Balance [0-14 points: 6 for sitting; 8 for standing]; (c) Sensation [0-24 points: 8 for light touch; 16 for position sense]; (d) Joint range of motion [0-44 points]; (e) Joint pain [0-44 points]. For all domains, a maximally affected person will score 0 while a fully functional person will have the highest score. All items are summed to provide a minimum score of 0 and a maximum score of 226. | 6 months |
| Change in the Fugl-Meyer Motor Total Score (FMMS) Total Score From Baseline at Month 6 | The FMMS is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in upper and lower limbs, reflex activity, volitional movement, and coordination. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance), and is comprised of a 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items are summed to determine scores for the 2 subscale scores, as well as a motor total score (total of the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. A maximally affected person will have a score of 0 while a fully functional person will have the highest score (i.e., 34 for LE-FMMS, 66 for UE-FMMS, 100 for FMMS) | 6 months |
| Change in the Fugl-Meyer Upper Extremity Motor Function Total Score From Baseline at Month 6 | The Fugl-Meyer Upper Extremity subscale (UE-FMMS) is comprised of 33 items that assess several dimensions of motor impairment, including range of motion in upper limbs, reflex activity, volitional movement, and coordination. Scoring is based on direct observation of performance and is scored using a 3-point ordinal scale, where 0=cannot perform; 1=partial motion; and 2=full motion Individual items are summed to provide ranging from 0 (minimum) to 66 (maximum). A maximally affected person will have a score of 0 while a fully functional person will a score of 66. | 6 months |
| Change in the Fugl-Meyer Lower Extremity Motor Function Total Score From Baseline at Month 6 | The Fugl-Meyer Lower Extremity subscale (LE-FMMS) is comprised of 17 items that assess several dimensions of motor impairment, including range of motion in lower limbs, reflex activity, volitional movement, and coordination. Scoring is based on direct observation of performance and is scored using a 3-point ordinal scale, where 0=cannot perform; 1=partial motion; and 2=full motion Individual items are summed to provide ranging from 0 (minimum) to 34 (maximum). A maximally affected person will have a score of 0 while a fully functional person will a score of 34. | 6 months |
| Stanford |
| California |
| 94305 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Derived |
| Steinberg GK, Kondziolka D, Wechsler LR, Lunsford LD, Coburn ML, Billigen JB, Kim AS, Johnson JN, Bates D, King B, Case C, McGrogan M, Yankee EW, Schwartz NE. Clinical Outcomes of Transplanted Modified Bone Marrow-Derived Mesenchymal Stem Cells in Stroke: A Phase 1/2a Study. Stroke. 2016 Jul;47(7):1817-24. doi: 10.1161/STROKEAHA.116.012995. Epub 2016 Jun 2. |
| BG002 | SB623 Implant (10.0M) | 10 million SB623 cells SB623: SB623, a modified stem-cell product |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| Title |
|---|
| Description |
|---|
| OG000 | SB623 Implant (2.5M) | 2.5 million SB623 cells SB623: SB623, a modified stem-cell product |
| OG001 | SB623 Implant (5.0M) | 5 million SB623 cells SB623: SB623, a modified stem-cell product |
| OG002 | SB623 Implant (10.0M) | 10 million SB623 cells SB623: SB623, a modified stem-cell product |
|
|
| Secondary | Change in the European Stroke Scale (ESS) Total Score From Baseline at Month 6 | The ESS is the sum of 14 items that are used to assess a patient who has recently had a stroke. These 14 items are level of consciousness, comprehension, speech, visual field, gaze, facial movement, arm in outstretched position, arm raising, extension of the wrist, fingers, leg maintained in position, leg flexing, dorsiflexion of the foot, and gait. A certain number of points are given for each parameter. The range of the total score of ESS is 0 - 100, with a completely normal person having a score of 100 and maximally affected person with a score of zero. | Intent-to-Treat (ITT) Population: Included all randomized subjects who completed the surgery treatment procedure (18 subjects). | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 6 months |
|
|
|
|
| Secondary | Change in the European Stroke Scale (ESS) Motor Function Total Score From Baseline at Month 6 | The ESS motor function score is a sum of the selected items: facial movement, arm in outstretched position, arm raising, extension of wrist, fingers, leg maintained in position, leg flexing, dorsiflexion of foot, and gait. A completely normal person will have a score of 66. The maximally affected person will have a score of zero. | Intent-to-Treat (ITT) Population: Included all randomized subjects who completed the surgery treatment procedure (18 subjects). | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 6 months |
|
|
|
| Secondary | Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score From Baseline at Month 6 | The NIHSS is a standardized method used to measure the level of impairment caused by a stroke. The scale consists of 11 items that measure several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. A certain number of points are given for each impairment uncovered during a focused neurological examination. A maximal score of 42 represents the most severe and devastating stroke with 0=no stroke, 1-4=minor stroke, 5-15=moderate stroke, 15-20=moderate/severe stroke, and 21-42=severe stroke. | Intent-to-Treat (ITT) Population: Included all randomized subjects who completed the surgery treatment procedure (18 subjects). | Posted | Mean | Standard Deviation | change in score on a scale from baseline | 6 months |
|
|
|
|
| Secondary | Change in the National Institutes of Health Stroke Scale (NIHSS) Motor Function Total Score From Baseline at Month 6 | The NIHSS is a standardized method used to measure the level of impairment caused by a stroke. The NIHSS Motor Function Total Score consists of 3 items: motor arm, motor leg, and limb ataxia, with 0 = no stroke and a maximal score of 18 = most severe impairment for motor function. | Intent-to-Treat (ITT) Population: Included all randomized subjects who completed the surgery treatment procedure (18 subjects). | Posted | Mean | Standard Deviation | change in score on a scale from baseline | 6 months |
|
|
|
| Secondary | Change in the Modified Rankin Scale (mRS) Response From Baseline at Month 6 | The mRS is a commonly used scale for measuring the degree of disability in daily activities for patients who have suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death. | Intent-to-Treat (ITT) Population: Included all randomized subjects who completed the surgery treatment procedure (18 subjects). | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 6 months |
|
|
|
| Secondary | Change in the Fugl-Meyer Total Score From Baseline at Month 6 | The Fugl-Meyer Scale is a stroke-specific, performance-based impairment index. The scale is comprised of 5 domains (motor score, sensation, balance, joint range of motion, and joint pain) with 155 items in total. Scoring is based on direct observation of performance. Scale items in all 5 domains are scored on the basis of ability to complete the item using a 3-point Likert-type ordinal scale, where 0=cannot perform, 1=performs partially, and 2=performs fully. Points are divided among the domains: (a) Motor performance [0 (hemiplegia) - 100 (normal motor performance) points]; (b) Balance [0-14 points: 6 for sitting; 8 for standing]; (c) Sensation [0-24 points: 8 for light touch; 16 for position sense]; (d) Joint range of motion [0-44 points]; (e) Joint pain [0-44 points]. For all domains, a maximally affected person will score 0 while a fully functional person will have the highest score. All items are summed to provide a minimum score of 0 and a maximum score of 226. | Intent-to-Treat (ITT) Population: Included all randomized subjects who completed the surgery treatment procedure (18 subjects). | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 6 months |
|
|
|
| Secondary | Change in the Fugl-Meyer Motor Total Score (FMMS) Total Score From Baseline at Month 6 | The FMMS is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in upper and lower limbs, reflex activity, volitional movement, and coordination. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance), and is comprised of a 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items are summed to determine scores for the 2 subscale scores, as well as a motor total score (total of the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. A maximally affected person will have a score of 0 while a fully functional person will have the highest score (i.e., 34 for LE-FMMS, 66 for UE-FMMS, 100 for FMMS) | Intent-to-Treat (ITT) Population: Included all randomized subjects who completed the surgery treatment procedure (18 subjects). | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 6 months |
|
|
|
| Secondary | Change in the Fugl-Meyer Upper Extremity Motor Function Total Score From Baseline at Month 6 | The Fugl-Meyer Upper Extremity subscale (UE-FMMS) is comprised of 33 items that assess several dimensions of motor impairment, including range of motion in upper limbs, reflex activity, volitional movement, and coordination. Scoring is based on direct observation of performance and is scored using a 3-point ordinal scale, where 0=cannot perform; 1=partial motion; and 2=full motion Individual items are summed to provide ranging from 0 (minimum) to 66 (maximum). A maximally affected person will have a score of 0 while a fully functional person will a score of 66. | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 6 months |
|
|
|
| Secondary | Change in the Fugl-Meyer Lower Extremity Motor Function Total Score From Baseline at Month 6 | The Fugl-Meyer Lower Extremity subscale (LE-FMMS) is comprised of 17 items that assess several dimensions of motor impairment, including range of motion in lower limbs, reflex activity, volitional movement, and coordination. Scoring is based on direct observation of performance and is scored using a 3-point ordinal scale, where 0=cannot perform; 1=partial motion; and 2=full motion Individual items are summed to provide ranging from 0 (minimum) to 34 (maximum). A maximally affected person will have a score of 0 while a fully functional person will a score of 34. | Posted | Mean | Standard Deviation | Change in score on a scale from baseline | 6 months |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | SB623 Implant (5.0M) | 5 million SB623 cells SB623: SB623, a modified stem-cell product | 0 | 6 | 3 | 6 | 6 | 6 |
| EG002 | SB623 Implant (10.0M) | 10 million SB623 cells SB623: SB623, a modified stem-cell product | 0 | 6 | 2 | 6 | 6 | 6 |
| Convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pneumocephalus | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pseudobulbar palsy | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Subdural hygroma | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Unresponsive to stimuli | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Neurological complication associated with device | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Lipids increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Non-high-density lipoprotein cholesterol increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |