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
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the ALS patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCI-186 | Drug | Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks | 0=worst; 48=best | baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death or a Specified State of Disease Progression | Any of "death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech" was defined as an event. | 24 weeks |
| Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28522181 | Result | Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15. | |
| 28872920 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MCI-186 | Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. |
| FG001 | Placebo of MCI-186 | Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Phase |
|
| |||||||||||||||||||||
| Open-label Phase |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MCI-186 | Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. |
| BG001 | Placebo of MCI-186 |
| 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 | Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks | 0=worst; 48=best | "1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group. "2 patients who did not reach the end of cycle 3" were excluded from the FAS in the Placebo of MCI-186 group. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline and 24 weeks |
|
Not provided
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 | Double-blind MCI-186 | MCI-186 in Double-blind. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). |
|
| MCI-186 in open label phase | Drug | All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will. |
|
| baseline and 24 weeks |
| Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks | The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best | baseline and 24 weeks |
| Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks | The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best | baseline and 24 weeks |
| Percentage of Participants With Adverse Events | 24 weeks |
| Percentage of Participants With Adverse Drug Reactions | 24 weeks |
| Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0) | 24 weeks |
| Percentage of Participants With Abnormal Values in Sensory Examinations | baseline and 24 weeks |
| WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 19 STUDY GROUP. Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):55-63. doi: 10.1080/21678421.2017.1364269. |
| 40878665 | Derived | Abrahao A, Da Silva P, Ciepielewska M, Zinman L. Real-world safety and tolerability of intravenous edaravone in patients with amyotrophic lateral sclerosis. Neurodegener Dis Manag. 2025 Dec;15(6):305-312. doi: 10.1080/17582024.2025.2552610. Epub 2025 Aug 29. |
| 37525592 | Derived | Brooks BR, Pioro EP, Sakata T, Takahashi F, Hagan M, Apple S. The effects of intervention with intravenous edaravone in Study 19 on hospitalization, tracheostomy, ventilation, and death in patients with amyotrophic lateral sclerosis. Muscle Nerve. 2023 Oct;68(4):397-403. doi: 10.1002/mus.27946. Epub 2023 Jul 31. |
| 28872913 | Derived | Takei K, Takahashi F, Liu S, Tsuda K, Palumbo J. Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):49-54. doi: 10.1080/21678421.2017.1361443. |
| Withdrawal by Subject |
|
| Due to a discontinuation criterion |
|
| NOT COMPLETED |
|
|
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
|
|
| Secondary | Number of Participants With Death or a Specified State of Disease Progression | Any of "death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech" was defined as an event. | Posted | Number | Count of Participants | 24 weeks |
|
|
|
| Secondary | Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks | "1 patient who did not reach the end of cycle 3" and "1 patient with missing data" were excluded from the FAS in the MCI-186 group. "2 patients who did not reach the end of cycle 3" were excluded from the FAS in the Placebo of MCI-186 group. | Posted | Least Squares Mean | Standard Error | percentage of FVC | baseline and 24 weeks |
|
|
|
| Secondary | Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks | The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best | "1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group. "2 patients who did not reach the end of cycle 3" and "3 patient with missing data" were excluded from the FAS in the Placebo of MCI-186 group. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline and 24 weeks |
|
|
|
| Secondary | Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks | The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best | "1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group. "2 patients who did not reach the end of cycle 3" and "2 patient with missing data" were excluded from the FAS in the Placebo of MCI-186 group. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline and 24 weeks |
|
|
|
| Secondary | Percentage of Participants With Adverse Events | Posted | Number | percentage of Participants | 24 weeks |
|
|
|
| Secondary | Percentage of Participants With Adverse Drug Reactions | Posted | Number | percentage of Participants | 24 weeks |
|
|
|
| Secondary | Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0) | Posted | Number | percentage of Participants | 24 weeks |
|
|
|
| Secondary | Percentage of Participants With Abnormal Values in Sensory Examinations | A note: Four patients of Placebo of MCI-186 group did not have data at 24 week. Therefore, concerning numbness (at 24 week) and staggering (at 24 week), the number of participants analysed are 64 in the both groups. | Posted | Number | percentage of Participants | baseline and 24 weeks |
|
|
|
| 11 |
| 69 |
| 57 |
| 69 |
| EG001 | Double-blind Placebo of MCI-186 | Placebo of MCI-186 in Double-blind. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion. | 16 | 68 | 51 | 68 |
| EG002 | Open-label MCI-186 (Double-blind MCI-186, Then Open-label) | MCI-186 in Open-label (Double-blind MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. | 17 | 65 | 53 | 65 |
| EG003 | Open-label MCI-186 (Double-blind Placebo, Then Open-label) | MCI-186 in Open-label (Double-blind Placebo of MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion. | 23 | 58 | 48 | 58 |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 17.0 |
|
| Bacterial infection | Infections and infestations | MedDRA 17.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Speech disorder | Nervous system disorders | MedDRA 17.0 |
|
| Depression | Psychiatric disorders | MedDRA 17.0 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 17.0 |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 17.0 |
|
| Shock | Vascular disorders | MedDRA 17.0 |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 |
|
| Gait disturbance | General disorders | MedDRA 17.0 |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 17.0 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 17.0 |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 17.0 |
|
| Blepharitis | Eye disorders | MedDRA 17.0 |
|
| Eye discharge | Eye disorders | MedDRA 17.0 |
|
| Retinal tear | Eye disorders | MedDRA 17.0 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 17.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 |
|
| Malocclusion | Gastrointestinal disorders | MedDRA 17.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 17.0 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 |
|
| Catheter site dermatitis | General disorders | MedDRA 17.0 |
|
| Feeling hot | General disorders | MedDRA 17.0 |
|
| Infusion site erythema | General disorders | MedDRA 17.0 |
|
| Infusion site pain | General disorders | MedDRA 17.0 |
|
| Infusion site phlebitis | General disorders | MedDRA 17.0 |
|
| Infusion site swelling | General disorders | MedDRA 17.0 |
|
| Injection site rash | General disorders | MedDRA 17.0 |
|
| Injection site reaction | General disorders | MedDRA 17.0 |
|
| Pain | General disorders | MedDRA 17.0 |
|
| Pyrexia | General disorders | MedDRA 17.0 |
|
| Swelling | General disorders | MedDRA 17.0 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.0 |
|
| Cellulitis | Infections and infestations | MedDRA 17.0 |
|
| Chronic sinusitis | Infections and infestations | MedDRA 17.0 |
|
| Conjunctivitis | Infections and infestations | MedDRA 17.0 |
|
| Dermatitis infected | Infections and infestations | MedDRA 17.0 |
|
| Device related infection | Infections and infestations | MedDRA 17.0 |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 |
|
| Gingival abscess | Infections and infestations | MedDRA 17.0 |
|
| Herpes zoster | Infections and infestations | MedDRA 17.0 |
|
| Infected dermal cyst | Infections and infestations | MedDRA 17.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 |
|
| Oral herpes | Infections and infestations | MedDRA 17.0 |
|
| Otitis externa | Infections and infestations | MedDRA 17.0 |
|
| Periodontitis | Infections and infestations | MedDRA 17.0 |
|
| Pharyngitis | Infections and infestations | MedDRA 17.0 |
|
| Postoperative wound infection | Infections and infestations | MedDRA 17.0 |
|
| Tinea infection | Infections and infestations | MedDRA 17.0 |
|
| Tinea pedis | Infections and infestations | MedDRA 17.0 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Blood bilirubin increased | Investigations | MedDRA 17.0 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 |
|
| Liver function test abnormal | Investigations | MedDRA 17.0 |
|
| White blood cell count decreased | Investigations | MedDRA 17.0 |
|
| Gout | Metabolism and nutrition disorders | MedDRA 17.0 |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.0 |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 17.0 |
|
| Decreased vibratory sense | Nervous system disorders | MedDRA 17.0 |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 |
|
| Dysgeusia | Nervous system disorders | MedDRA 17.0 |
|
| Headache | Nervous system disorders | MedDRA 17.0 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 |
|
| Sciatica | Nervous system disorders | MedDRA 17.0 |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 |
|
| Dysuria | Renal and urinary disorders | MedDRA 17.0 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.0 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Hypertension | Vascular disorders | MedDRA 17.0 |
|
| Hypotension | Vascular disorders | MedDRA 17.0 |
|
| Phlebitis | Vascular disorders | MedDRA 17.0 |
|
| Vasculitis | Vascular disorders | MedDRA 17.0 |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 |
|
| Gingivitis | Infections and infestations | MedDRA 17.0 |
|
| Herpes simplex | Infections and infestations | MedDRA 17.0 |
|
| Influenza | Infections and infestations | MedDRA 17.0 |
|
| Oral candidiasis | Infections and infestations | MedDRA 17.0 |
|
| Tinea cruris | Infections and infestations | MedDRA 17.0 |
|
| Catheter site infection | Infections and infestations | MedDRA 17.0 |
|
| Seasonal allergy | Immune system disorders | MedDRA 17.0 |
|
| Anxiety | Psychiatric disorders | MedDRA 17.0 |
|
| Depression | Psychiatric disorders | MedDRA 17.0 |
|
| Neurosis | Psychiatric disorders | MedDRA 17.0 |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 17.0 |
|
| Speech disorder | Nervous system disorders | MedDRA 17.0 |
|
| Tremor | Nervous system disorders | MedDRA 17.0 |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 17.0 |
|
| Diplopia | Eye disorders | MedDRA 17.0 |
|
| Dry eye | Eye disorders | MedDRA 17.0 |
|
| Eczema eyelids | Eye disorders | MedDRA 17.0 |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 17.0 |
|
| Arrhythmia | Cardiac disorders | MedDRA 17.0 |
|
| Tachycardia | Cardiac disorders | MedDRA 17.0 |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 17.0 |
|
| Shock | Vascular disorders | MedDRA 17.0 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA 17.0 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 17.0 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 17.0 |
|
| Anal inflammation | Gastrointestinal disorders | MedDRA 17.0 |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 17.0 |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 17.0 |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 |
|
| Haematuria | Renal and urinary disorders | MedDRA 17.0 |
|
| Incontinence | Renal and urinary disorders | MedDRA 17.0 |
|
| Nocturia | Renal and urinary disorders | MedDRA 17.0 |
|
| Gait disturbance | General disorders | MedDRA 17.0 |
|
| Malaise | General disorders | MedDRA 17.0 |
|
| Catheter site haemorrhage | General disorders | MedDRA 17.0 |
|
| Catheter site erythema | General disorders | MedDRA 17.0 |
|
| Catheter site inflammation | General disorders | MedDRA 17.0 |
|
| Infusion site pruritus | General disorders | MedDRA 17.0 |
|
| Puncture site swelling | General disorders | MedDRA 17.0 |
|
| Blood pressure increased | Investigations | MedDRA 17.0 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.0 |
|
| Blood urine present | Investigations | MedDRA 17.0 |
|
| White blood cell count increased | Investigations | MedDRA 17.0 |
|
| Protein urine present | Investigations | MedDRA 17.0 |
|
| Bite | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Wound compliation | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 17.0 |
|
Not provided
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Loss of upper limbs function |
|
| Tracheotomy |
|
| Use of respirator |
|
| Use of tube feeding |
|
| Loss of useful speech |
|
| Liver function test abnormal |
|
| White blood cell count decreased |
|
| Staggering (at baseline) |
|
| Staggering (at 24 week) |
|