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| Name | Class |
|---|---|
| California Institute for Regenerative Medicine (CIRM) | OTHER |
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This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete Neurotrophic factors (NTFs).
The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells
Neurotrophic factors (NTFs) are potent survival factors for embryonic, neonatal, and adult neurons and are considered potential therapeutic candidates for ALS. Delivery of multiple NTFs to the immediate environment of afflicted neurons in ALS patients is expected to improve their survival and thus slow down disease progression and alleviate symptoms. NTF-secreting mesenchymal stromal cells (MSC-NTF cells) are a novel cell-therapeutic approach aimed at effectively delivering NTFs directly to the site of damage in ALS patients.
Participants meeting the inclusion and exclusion criteria will be randomized and will undergo bone-marrow aspiration. MSC of the participants randomized to the treatment group will be induced into MSC-NTF cells. Participants will undergo a total of three intrathecal (IT) transplantations with NurOwn® (MSC-NTF cells) or matching placebo at three bi-monthly intervals
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NurOwn® (MSC-NTF cells) | Active Comparator | Three Intrathecal administrations of NurOwn® (MSC-NTF cells) at bi-monthly intervals |
|
| Placebo | Placebo Comparator | Three Intrathecal administrations of Placebo at bi-monthly intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NurOwn® (MSC-NTF cells) | Biological | NurOwn® (MSC-NTF): One course of treatment that includes three separate intrathecal injections of 100-125 x 10^6 cells every 8 weeks NurOwn® (MSC-NTF): Autologous, bone marrow-derived, mesenchymal stem cells secreting neurotrophic factors |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of NurOwn® Treated Participants With a ≥1.25 Points/Month Improvement in Post-treatment Slope vs. Pre-treatment Slope in ALSFRS-R Score at 28 Weeks Following the First Treatment as Compared to Placebo | The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better. | 28 weeks following the first intrathecal injection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Disease Progression is Halted or Improved as Measured by a 100% or Greater Improvement in Post-treatment Slope vs. Pre-treatment Slope in ALSFRS-R Score of NurOwn® Treatment vs. Placebo | The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merit E. Cudkowicz, MD | Massachusetts General Hospital | Principal Investigator |
| Robert H. Brown, MD, PhD | UMass Medical School | Principal Investigator |
| Anthony J. Windebank, MD | Mayo Clinic | Principal Investigator |
| Namita A. Goyal, MD | UC Irvine | Principal Investigator |
| Robert G. Miller, MD | California Pacific Medical Center (CPM) Research Institute | Principal Investigator |
| Robert Baloh, MD, Ph.D. | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine Alpha Stem Cell Clinic | Irvine | California | 92697 | United States | ||
| Cedars-Sinai Medical Center |
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The most common reasons that participants did not meet inclusion criteria were failure to meet the SVC inclusion criterion at the Screening Visit or the required pre-treatment decline in ALSFRSR total score at the randomization visit. From the ITT population, 3 participants in the NurOwn group and 4 participants in the placebo group discontinued prior to treatment.
The first participant in Study BCT-002-US signed informed consent on 28 August 2017 The last participant visit took place on 29 September 2020. The study was conducted at 6 clinical sites in the USA. A total of 263 participants were screened for the study, and 196 participants (74.5% of participants screened) were randomly assigned (1:1) to treatment with either NurOwn or placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | NurOwn® (MSC-NTF Cells) | NurOwn® (MSC-NTF): One course of treatment that includes three separate intrathecal injections of 100-125 x 10'6 cells every 8 weeks NurOwn® (MSC-NTF): Autologous, bone marrow-derived, mesenchymal stem cells secreting neurotrophic factors Bone marrow aspiration |
| FG001 | Placebo | One course of treatment that includes three separate intrathecal injections of Placebo every 8 weeks Placebo: liquid solution in syringe for injection Bone marrow aspiration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic characteristics were balanced between NurOwn and placebo treatment groups with no statistically significant differences at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | NurOwn® (MSC-NTF Cells) | NurOwn® (MSC-NTF): One course of treatment that includes three separate intrathecal injections of 100-125 x 10'6 cells every 8 weeks NurOwn® (MSC-NTF): Autologous, bone marrow-derived, mesenchymal stem cells secreting neurotrophic factors Bone marrow aspiration |
| BG001 |
| 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 | The Proportion of NurOwn® Treated Participants With a ≥1.25 Points/Month Improvement in Post-treatment Slope vs. Pre-treatment Slope in ALSFRS-R Score at 28 Weeks Following the First Treatment as Compared to Placebo | The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better. | The modified intent-to-treat (mITT) population was defined as all participants who were randomized, treated and had at least three ALSFRS-R assessments: one pre-treatment assessments of ALSFRS-R prior to the baseline assessment, a baseline assessment and one post-treatment assessment. | Posted | Count of Participants | Participants | 28 weeks following the first intrathecal injection |
from the screening visit through the end of the study period (28 weeks after first treatment)
AE means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
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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 | NurOwn® (MSC-NTF Cells) | NurOwn® (MSC-NTF): One course of treatment that includes three separate intrathecal injections of 100-125 x 10^6 cells every 8 weeks NurOwn® (MSC-NTF): Autologous, bone marrow-derived, mesenchymal stem cells secreting neurotrophic factors Bone marrow aspiration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
This trial had a unique and atypical trial population that included more participants than anticipated with advanced ALS, who had a low ALSFRS-R score. As compared with recent large ALS clinical trials, this study population is an outlier, with a mean overall ALSFRS-R score at baseline lower than other studies, and this impacted the power of this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Brainstorm Cell Therapeutics | +1-201-488-0460 | ClinicalTrial@brainstorm-cell.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2020 | Nov 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2020 | Dec 1, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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Randomized, Double-Blind, Placebo-Controlled Multicenter Study
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This is a double-blind study where the investigators, participants and all sponsor and CRO personnel involved in the conduct, data management or analysis of the study will remain blinded to the treatment assignments
|
| Placebo | Other | One course of treatment that includes three separate intrathecal injections of Placebo every 8 weeks Placebo: liquid solution in syringe for injection |
|
| Bone Marrow aspiration | Other | Bone Marrow aspiration |
|
| 28 weeks following the first intrathecal injection |
| Score of NurOwn® (MSC-NTF Cells) Treated Patients vs. Placebo Treated Patients as Measured by Change From Baseline in ALSFRS-R Score at Week 28 | The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better. | 28 weeks following the first intrathecal injection |
| NurOwn® (MSC-NTF Cells) Treated Patients vs. Placebo Treated Patients as Measured by the Combined Assessment of Function and Survival at 28 Weeks | The combined Assessment of Function and Survival (CAFS) is a composite endpoint based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. On the ALSFRS-R, 12 functions are rated on 5-point ordinal rating scales (from 0 to 4) with a total score range (minimum and maximum score) of 0-48 (sum of all 12 items). The higher the score the better functioning. For the survival endpoint, the longer time the better outcome. A patient's CAFS score represents a patient's rank in the study based on comparing the patient's outcome for both the change in ALSFRS-R and the time to death to all other patients in the study in a pairwise fashion. The ranked scores range from 001 to 189 (the number of subjects in the mITT population) with larger rank score numbers associated with a better outcome. The reported values are the mean rank scores in each group for the composite endpoint. | 28 weeks following the first intrathecal injection |
| Los Angeles |
| California |
| 90048 |
| United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Adverse Event |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Early Discontinuation |
|
| Placebo |
One course of treatment that includes three separate intrathecal injections of Placebo every 8 weeks Placebo: liquid solution in syringe for injection Bone marrow aspiration |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| 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 |
|
| Baseline Amyotrophic Lateral Sclerosis Functional Rating ScaleScore | The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better. | Mean | Standard Deviation | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | NurOwn® (MSC-NTF Cells) | NurOwn® (MSC-NTF): One course of treatment that includes three separate intrathecal injections of 100-125 x 10'6 cells every 8 weeks NurOwn® (MSC-NTF): Autologous, bone marrow-derived, mesenchymal stem cells secreting neurotrophic factors Bone marrow aspiration |
| OG001 | Placebo | One course of treatment that includes three separate intrathecal injections of Placebo every 8 weeks Placebo: liquid solution in syringe for injection Bone marrow aspiration |
|
|
|
| Secondary | Number of Participants Whose Disease Progression is Halted or Improved as Measured by a 100% or Greater Improvement in Post-treatment Slope vs. Pre-treatment Slope in ALSFRS-R Score of NurOwn® Treatment vs. Placebo | The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better. | The modified intent-to-treat (mITT) population was defined as all participants who were randomized, treated and had at least three ALSFRS-R assessments: one pre-treatment assessments of ALSFRS-R prior to the baseline assessment, a baseline assessment and one post-treatment assessment. | Posted | Count of Participants | Participants | 28 weeks following the first intrathecal injection |
|
|
|
|
| Secondary | Score of NurOwn® (MSC-NTF Cells) Treated Patients vs. Placebo Treated Patients as Measured by Change From Baseline in ALSFRS-R Score at Week 28 | The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better. | The modified intent-to-treat (mITT) population was defined as all participants who were randomized, treated and had at least three ALSFRS-R assessments: one pre-treatment assessments of ALSFRS-R prior to the baseline assessment, a baseline assessment and one post-treatment assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | 28 weeks following the first intrathecal injection |
|
|
|
|
| Secondary | NurOwn® (MSC-NTF Cells) Treated Patients vs. Placebo Treated Patients as Measured by the Combined Assessment of Function and Survival at 28 Weeks | The combined Assessment of Function and Survival (CAFS) is a composite endpoint based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. On the ALSFRS-R, 12 functions are rated on 5-point ordinal rating scales (from 0 to 4) with a total score range (minimum and maximum score) of 0-48 (sum of all 12 items). The higher the score the better functioning. For the survival endpoint, the longer time the better outcome. A patient's CAFS score represents a patient's rank in the study based on comparing the patient's outcome for both the change in ALSFRS-R and the time to death to all other patients in the study in a pairwise fashion. The ranked scores range from 001 to 189 (the number of subjects in the mITT population) with larger rank score numbers associated with a better outcome. The reported values are the mean rank scores in each group for the composite endpoint. | The modified intent-to-treat (mITT) population was defined as all participants who were randomized, treated and had at least three ALSFRS-R assessments: one pre-treatment assessments of ALSFRS-R prior to the baseline assessment, a baseline assessment and one post-treatment assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | 28 weeks following the first intrathecal injection |
|
|
|
|
| 10 |
| 95 |
| 23 |
| 95 |
| 93 |
| 95 |
| EG001 | Placebo | One course of treatment that includes three separate intrathecal injections of Placebo every 8 weeks Placebo: liquid solution in syringe for injection Bone marrow aspiration | 4 | 94 | 17 | 94 | 92 | 94 |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory muscle weakness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Disease progression | General disorders | Non-systematic Assessment |
|
| Euthanasia | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | Non-systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Postoperative fever | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural anxiety | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Injection site pain | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |