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The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in 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. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MCI-186 |
|
| 2 | Placebo Comparator | Placebo of MCI-186 |
|
| 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). Then 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 | ALSFRS-R Score: 0=worst; 48=best | baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Death or a Specified State of Disease Progression | Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event. | 24 weeks |
| Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koji Abe, professor | Graduate School of Medicine and Dentistry, Okayama University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25286015 | Result | Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MCI-186 | Edaravone 60 mg, intravenously infused over 60 min once daily. |
| FG001 | Placebo of MCI-186 | Edaravone matched placebo, intravenously infused over 60 min once daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MCI-186 | Edaravone 60 mg, intravenously infused over 60 min once daily. |
| BG001 | Placebo of MCI-186 | Edaravone matched placebo, intravenously infused over 60 min once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | ALSFRS-R Score: 0=worst; 48=best | "1 patient with diseases other than ALS" and "1 patient who did not reach the end of cycle 3" were excluded from the FAS in the MCI-186 group. "5 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
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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 | MCI-186 | Edaravone 60 mg, intravenously infused over 60 min once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 11.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| 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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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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|
|
| Placebo of MCI-186 | Drug | Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). |
|
| 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. Worst=0, Best=102 | 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, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40 | baseline and 24 weeks |
| Percentage of Participants With Adverse Events | 24 weeks |
| Percentage of Participants With Adverse Drug Reactions | 24 weeks |
| Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group | 24 weeks |
| Percentage of Participants With Abnormal Changes in Sensory Examinations | 24 weeks |
| Withdrawal by Subject |
|
| Tracheotomy due to worsening of ALS |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Death or a Specified State of Disease Progression | Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event. | "1 patient with diseases other than ALS" was excluded from the FAS in the MCI-186 group. | Posted | Number | participants | 24 weeks |
|
|
|
| Secondary | Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks | "1 patient with diseases other than ALS" and "1 patient who did not reach the end of cycle 3" were excluded from the FAS in the MCI-186 group. "5 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. Worst=0, Best=102 | "1 patient with diseases other than ALS", "1 patient who did not reach the end of cycle 3" and "5 patients with missing data" were excluded from the FAS in the MCI-186 group. "5 patients who did not reach the end of cycle 3" and "2 patients 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, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40 | "1 patient with diseases other than ALS", "1 patient who did not reach the end of cycle 3" and "5 patients with missing data" were excluded from the FAS in the MCI-186 group. "5 patients who did not reach the end of cycle 3" and "4 patients 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 | Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group | "1 patient with missing data" was excluded from the FAS in the Placebo of MCI-186 group. | Posted | Number | percentage of participants | 24 weeks |
|
|
|
| Secondary | Percentage of Participants With Abnormal Changes in Sensory Examinations | Posted | Number | percentage of participants | 24 weeks |
|
|
|
| 18 |
| 102 |
| 88 |
| 102 |
| EG001 | Placebo of MCI-186 | Edaravone matched placebo, intravenously infused over 60 min once daily. | 24 | 104 | 91 | 104 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 |
|
| Ascites | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abasia | General disorders | MedDRA 11.1 |
|
| Gait disturbance | General disorders | MedDRA 11.1 |
|
| Oedema peripheral | General disorders | MedDRA 11.1 |
|
| Cellulitis | Infections and infestations | MedDRA 11.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Mastication disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
|
| Dyslalia | Nervous system disorders | MedDRA 11.1 |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 |
|
| Depression | Psychiatric disorders | MedDRA 11.1 |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Palpitations | Cardiac disorders | MedDRA 11.1 |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 11.1 |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 11.1 |
|
| Eustachian tube patulous | Ear and labyrinth disorders | MedDRA 11.1 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 11.1 |
|
| Astigmatism | Eye disorders | MedDRA 11.1 |
|
| Cataract | Eye disorders | MedDRA 11.1 |
|
| Conjunctivitis | Eye disorders | MedDRA 11.1 |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 11.1 |
|
| Dry eye | Eye disorders | MedDRA 11.1 |
|
| Eye discharge | Eye disorders | MedDRA 11.1 |
|
| Eye pain | Eye disorders | MedDRA 11.1 |
|
| Eye pruritus | Eye disorders | MedDRA 11.1 |
|
| Myodesopsia | Eye disorders | MedDRA 11.1 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 |
|
| Anal prolapse | Gastrointestinal disorders | MedDRA 11.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 11.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Tooth loss | Gastrointestinal disorders | MedDRA 11.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abasia | General disorders | MedDRA 11.1 |
|
| Catheter site erythema | General disorders | MedDRA 11.1 |
|
| Catheter site inflammation | General disorders | MedDRA 11.1 |
|
| Catheter site pain | General disorders | MedDRA 11.1 |
|
| Chest pain | General disorders | MedDRA 11.1 |
|
| Feeling abnormal | General disorders | MedDRA 11.1 |
|
| Gait disturbance | General disorders | MedDRA 11.1 |
|
| Infusion site reaction | General disorders | MedDRA 11.1 |
|
| Injection site phlebitis | General disorders | MedDRA 11.1 |
|
| Local swelling | General disorders | MedDRA 11.1 |
|
| Malaise | General disorders | MedDRA 11.1 |
|
| Oedema | General disorders | MedDRA 11.1 |
|
| Oedema peripheral | General disorders | MedDRA 11.1 |
|
| Pyrexia | General disorders | MedDRA 11.1 |
|
| Thirst | General disorders | MedDRA 11.1 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 11.1 |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 11.1 |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 11.1 |
|
| Seasonal allergy | Immune system disorders | MedDRA 11.1 |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 |
|
| Cystitis | Infections and infestations | MedDRA 11.1 |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 11.1 |
|
| Folliculitis | Infections and infestations | MedDRA 11.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 |
|
| Herpes zoster | Infections and infestations | MedDRA 11.1 |
|
| Influenza | Infections and infestations | MedDRA 11.1 |
|
| Nail infection | Infections and infestations | MedDRA 11.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 |
|
| Onychomycosis | Infections and infestations | MedDRA 11.1 |
|
| Oral herpes | Infections and infestations | MedDRA 11.1 |
|
| Otitis externa | Infections and infestations | MedDRA 11.1 |
|
| Otitis media | Infections and infestations | MedDRA 11.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 |
|
| Purulence | Infections and infestations | MedDRA 11.1 |
|
| Rhinitis | Infections and infestations | MedDRA 11.1 |
|
| Tinea capitis | Infections and infestations | MedDRA 11.1 |
|
| Tinea cruris | Infections and infestations | MedDRA 11.1 |
|
| Tinea infection | Infections and infestations | MedDRA 11.1 |
|
| Tinea pedis | Infections and infestations | MedDRA 11.1 |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 |
|
| Tooth abscess | Infections and infestations | MedDRA 11.1 |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.1 |
|
| Blood pressure increased | Investigations | MedDRA 11.1 |
|
| Blood urea increased | Investigations | MedDRA 11.1 |
|
| Blood urine present | Investigations | MedDRA 11.1 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 |
|
| Glucose urine present | Investigations | MedDRA 11.1 |
|
| Liver function test abnormal | Investigations | MedDRA 11.1 |
|
| Protein urine present | Investigations | MedDRA 11.1 |
|
| White blood cell count decreased | Investigations | MedDRA 11.1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 |
|
| Dizziness postural | Nervous system disorders | MedDRA 11.1 |
|
| Headache | Nervous system disorders | MedDRA 11.1 |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 11.1 |
|
| Migraine | Nervous system disorders | MedDRA 11.1 |
|
| Pallanaesthesia | Nervous system disorders | MedDRA 11.1 |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 11.1 |
|
| Sensory disturbance | Nervous system disorders | MedDRA 11.1 |
|
| Tension headache | Nervous system disorders | MedDRA 11.1 |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 11.1 |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.1 |
|
| Nocturia | Renal and urinary disorders | MedDRA 11.1 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 11.1 |
|
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA 11.1 |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 11.1 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Acrodermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Essential hypertension | Vascular disorders | MedDRA 11.1 |
|
| Haematoma | Vascular disorders | MedDRA 11.1 |
|
| Hypertension | Vascular disorders | MedDRA 11.1 |
|
| Phlebitis | Vascular disorders | MedDRA 11.1 |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 |
|
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 arm function |
|
| tracheotomy |
|
| use of respirator |
|
| use of tube feeding |
|
| Vibratory sensation |
|