Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004145-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner. Study population is patients diagnosed, with possible or probable parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa
The overall design is a parallel group, placebo controlled, double blind study. The target population are participants diagnosed with possible or probable parkinsonian variant of Multiple System Atrophy who are on stable doses of levodopa.
Trial participation will be up to a maximum duration of 14 weeks and will comprise a screening period (up to 2 weeks), a 2-week run in period during which subjects will receive 1 tablet (either 100 mg safinamide or matching placebo), followed by a 10-week period, during which study participants will take 2 tablets of study medication (200 mg safinamide or placebo) once daily, taken in the morning in addition to their morning levodopa dose. A telephone follow-up call will be performed 2 weeks after the end of treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Safinamide methanesulfonate film-coated tablets once daily |
|
| Placebo | Placebo Comparator | Safinamide Methanesulfonate matching placebo film-coated tablets once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safinamide Methanesulfonate | Drug | 100 mg (free base) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | While evaluating safety and tolerability of safinamide, 200 mg od, compared with placebo, severity of TEAEs, their relationship to study drug, their seriousness and their consequences were assessed. TEAEs were defined as adverse events (AEs) that started after the first dose of study drug. | Throughout the study, from baseline (and at each interim visit) to telephone follow-up visit at 14 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in the Goniometric Measurement for Anterior Displacement | To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of "anterior" displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90. |
Not provided
Inclusion Criteria:
Participant must be 30 to 80 years of age inclusive, at the time of signing the informed consent;
Participants who are diagnosed (with MRI confirmation) with possible or probable parkinsonian variant of Multiple System Atrophy less than 2 years ago;
Participants with an anticipated survival of at least 3 years in the opinion of the investigator;
Female not pregnant, not breastfeeding, and at least one of the following conditions applies:
Capable of giving signed informed consent
Exclusion Criteria:
History of neurosurgical procedure, including stereotactic surgery;
History of Deep Brain Stimulation (DBS);
History of bipolar disorder, severe depression, schizophrenia or other psychotic disorder;
History of drug and/or alcohol abuse within 12 months prior to screening as defined by the current edition of the Diagnostic and Statistical Manual of Mental Disorders;
History of dementia (DSM-V criteria);
Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease;
Active hepatitis B or C;
History of human immunodeficiency virus (HIV) infection;
Subjects not able to swallow oral medications;
Subjects with severe orthostatic symptoms;
Impaired ambulation, i.e. falling more than once per week, bedridden patients or confined to a wheelchair during the whole day;
Subjects with active malignant neoplasms;
Movement disorders other than MSA (e.g. Parkinson Disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, pharmacological or post-encephalic parkinsonism);
Any clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect the results of the study;
Not on a stable regime, for at least 4 weeks prior to the randomization (baseline visit), of
Patients should not have received treatment with monoamine oxidase inhibitors in the 2 weeks prior to the randomization visit, nor treatment with levodopa infusion, pethidine, opiates, opioids, fluoxetine, fluvoxamine in the 4 weeks prior to the randomization visit;
Patients should not have received treatment with an oral or depot neuroleptic within 12 weeks prior to the randomization visit;
Use of any investigational drug within 30 days prior to screening or 5 half-lives, whichever is the longest;
Montreal Cognitive Assessment (MoCA) ≤ 20;
Laboratory assessments showing moderate or severe hepatic impairment (2x ULN);
Allergy/sensitivity or contraindications to the investigational medicinal products (IMPs) or their excipients, anticonvulsants, levodopa or other anti-parkinsonian drugs;
Any clinically significant condition which, in the opinion of the Investigator, would not be compatible with study participation or represent a risk for patients while in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charlotte Keywood, MD | Zambon SpA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università di Bologna | Bologna | 40123 | Italy | |||
| AAST degli Spedali Civili di Brescia |
Participants (males and females between 30 and 80 years) diagnosed with possible or probable parkinsonian variant of MSA <2 years before, with MRI consistent with the diagnosis of MSA, and not suggesting an alternative explanation to the clinical diagnosis of MSA, and with an anticipated survival of at least 3 years in the opinion of the Investigator.
Approximately 56 participants were planned to be screened in order to achieve 49 participants randomly assigned (2:1) to study drug and 42 evaluable participants, resulting in a planned estimated total of 32 evaluable participants receiving safinamide and 17 evaluable participants receiving matching placebo. Only 42 completed the study while 7 discontinued it.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Safinamide | Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. |
| FG001 | Placebo | Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The ITT Population included all randomized participants. This population was used for describing all the demographic characteristics and all efficacy variables.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safinamide | Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. |
| 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 | TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | While evaluating safety and tolerability of safinamide, 200 mg od, compared with placebo, severity of TEAEs, their relationship to study drug, their seriousness and their consequences were assessed. TEAEs were defined as adverse events (AEs) that started after the first dose of study drug. | The Safety Population included all randomized participants who took at least 1 dose of study drug. This population was used to summarize all safety data. | Posted | Number | events | Throughout the study, from baseline (and at each interim visit) to telephone follow-up visit at 14 week. |
|
At baseline, at interim visits (Weeks 2 - 8, and more precisely at days 14 ± 3, 28 ± 3, 56 ± 3), at End of Treatment visit (EOT) at Week 12 (84 ± 3 days), and at follow-up call at week 14 ( 98 ± 3).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safinamide | Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac respiratory arrest | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA version 23.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trial - Charlotte Keywood, MD | Zambon S.p.A. | +39 02 665241 | charlotte.keywood@zambongroup.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2020 | Jun 21, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2021 | Jun 21, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019578 | Multiple System Atrophy |
| C563206 | Thyroid Dyshormonogenesis 2A |
| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C092797 | safinamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Safinamide Methanesulfonate matching placebo | Drug | 100 mg placebo |
|
|
| From baseline to week 12 |
| Change From Baseline to Week 12 in the Goniometric Measurement for Lateral Displacement | To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of "lateral" displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90. | From baseline to week 12 |
| Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (ITT Population) | UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health. UMSARS has the following domains: Part I - Activities of Daily Living score (12 questions ranged in 0-4 [total score 0-48]) that evaluates motor including autonomic activities Part II - Motor Examination score (14 questions, [total score 0-56]) Part III - Autonomic Examination Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total dependent and helpless). Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation. | From baseline to week 12 |
| Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (PP Population) | UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health. UMSARS has the following domains: Part I - Activities of Daily Living score (12 questions ranged in 0-4 [total score 0-48]) that evaluates motor including autonomic activities Part II - Motor Examination score (14 questions, [total score 0-56]) Part III - Autonomic Examination Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total dependent and helpless). Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation. | From baseline to week 12 |
| Change From Baseline to Week 12 in Multiple System Atrophy Health-Related Quality of Life (MSA-QoL) Scale | The MSA-QoL is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 to 160, with 0= 'no problem' and 160= "extreme problem". | From baseline to week 12 |
| Change From Baseline to Week 12 in Montreal Cognitive Assessment (MoCA) Scale | The Montreal Cognitive Assessment (MoCA) was designed as a tool for rapid screening for mild cognitive impairment. It evaluates different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructive skills, abstraction, calculation and orientation. The administration time of the MoCa is 10 minutes. The MoCA scale ranges from 0 to 30, with higher scores indicating better cognitive functioning. | From baseline to week 12 |
| Change From Baseline to Week 12 in Unified Dystonia Rating Scale (UDRS) | UDRS consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment. The Unified Dystonia Rating Scale (UDRS) assesses the motor severity and duration of dystonia in 14 body areas. The total score, obtained as the sum of the severity and duration factors, ranges from 0 to 112. Higher scores indicate worse dystonia. | From baseline to week 12 |
| Brescia |
| 25123 |
| Italy |
| San Raffaele Cassino | Cassino | 03043 | Italy |
| Fondazione Università "G. D'Annunzio" | Chieti | 66013 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli | Naples | 80138 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Azienda Opsedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio - Ruggi d'Aragona | Salerno | 84131 | Italy |
| Azienda Ospedaliera Santa Maria di Terni | Terni | 05100 | Italy |
| Hospital General Universitario de Elche | Alicante | 03203 | Spain |
| Hospital de Cruces | Barakaldo | 48903 | Spain |
| Hospital de la Santa Creu i Sant Pau Barcelona | Barcelona | 08025 | Spain |
| Hospital Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28304 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen de Rocio | Seville | 41013 | Spain |
| clinical deterioration |
|
| BG001 |
| Placebo |
Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. |
|
|
| Secondary | Change From Baseline to Week 12 in the Goniometric Measurement for Anterior Displacement | To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of "anterior" displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90. | The ITT Population included all randomized participants. This population was used for all efficacy variables. | Posted | Mean | Standard Deviation | degrees | From baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in the Goniometric Measurement for Lateral Displacement | To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on quality of life (change in anterior displacement). The goniometric measurement consists in the posture evaluation of the patient, measuring through a goniometer the angle of the flexion of the trunk. Goniometric measurement of "lateral" displacement was determined using a wall goniometer and expressing the value in degrees in the range of 0 to 90. | The ITT Population included all randomized participants. This population was used for all efficacy variables. | Posted | Mean | Standard Deviation | degrees | From baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (ITT Population) | UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health. UMSARS has the following domains: Part I - Activities of Daily Living score (12 questions ranged in 0-4 [total score 0-48]) that evaluates motor including autonomic activities Part II - Motor Examination score (14 questions, [total score 0-56]) Part III - Autonomic Examination Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total dependent and helpless). Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation. | The ITT Population included all randomized participants. This population was used for all efficacy variables. | Posted | Mean | Standard Deviation | score on a scale | From baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in Unified Multiple System Atrophy Rating Scale (UMSARS), Part II (PP Population) | UMSARS is a validated, disease-specific scale representing the diverse signs and symptoms in MSA. Higher scores on the UMSARS scales mean poorer health. UMSARS has the following domains: Part I - Activities of Daily Living score (12 questions ranged in 0-4 [total score 0-48]) that evaluates motor including autonomic activities Part II - Motor Examination score (14 questions, [total score 0-56]) Part III - Autonomic Examination Part IV - Global disability scale ((1=completely independent; 2=not completely independent; 3=more dependent; 4=very dependent; 5=total dependent and helpless). Only UMSARS Part II total score is reported, which was obtained as the sum of the 14 items in the scale. If any of the items were missing, then the total score was considered missing. Higher scores indicate worse functional situation. | The Per Protocol Population will include all randomized participants who do not have any entry criteria violations or protocol deviations that could significantly impact the assessment or interpretation of efficacy data. | Posted | Mean | Standard Deviation | score on a scale | From baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in Multiple System Atrophy Health-Related Quality of Life (MSA-QoL) Scale | The MSA-QoL is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 to 160, with 0= 'no problem' and 160= "extreme problem". | The ITT Population included all randomized participants. This population was used for all efficacy variables | Posted | Mean | Standard Deviation | units on a scale | From baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in Montreal Cognitive Assessment (MoCA) Scale | The Montreal Cognitive Assessment (MoCA) was designed as a tool for rapid screening for mild cognitive impairment. It evaluates different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructive skills, abstraction, calculation and orientation. The administration time of the MoCa is 10 minutes. The MoCA scale ranges from 0 to 30, with higher scores indicating better cognitive functioning. | The ITT Population included all randomized participants. This population was used for all efficacy variables. | Posted | Mean | Standard Deviation | score on a scale | From baseline to week 12 |
|
|
|
|
| Secondary | Change From Baseline to Week 12 in Unified Dystonia Rating Scale (UDRS) | UDRS consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment. The Unified Dystonia Rating Scale (UDRS) assesses the motor severity and duration of dystonia in 14 body areas. The total score, obtained as the sum of the severity and duration factors, ranges from 0 to 112. Higher scores indicate worse dystonia. | The ITT Population included all randomized participants. This population was used for all efficacy variables. | Posted | Mean | Standard Deviation | units on a scale | From baseline to week 12 |
|
|
|
|
| 1 |
| 32 |
| 2 |
| 32 |
| 21 |
| 32 |
| EG001 | Placebo | Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. | 0 | 17 | 0 | 17 | 11 | 17 |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Parkinsonian gait | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Dependent rubor | Vascular disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA version 23.0 | Systematic Assessment |
|
Not provided
Not provided
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |