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This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 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 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times. |
| 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 To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed. | baseline (seventh cycle) and at 24 week (twelfth cycle) |
| 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 arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event. | 24 weeks (from seventh cycle to twelfth cycle) |
| Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koji Abe, professor | Graduate School of Medicine and Dentistry, Okayama University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital Organization Miyagi National Hospital | Watari-gun | Miyagi | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28872918 | Result | WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 17 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):20-31. doi: 10.1080/21678421.2017.1362000. | |
| 28872914 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | MCI-186 - Placebo of MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| FG001 | MCI-186 - MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| FG002 | Placebo of MCI-186 - MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MCI-186 - Placebo of MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| 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 | 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 To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed. | "1 patient with diseases other than ALS" and "4 patients with missing data" were excluded from the FAS in the MCI-186 - Placebo of MCI-186group. "5 patients with missing data" were excluded from the FAS in the MCI-186 - MCI-186 group. "14 patients with missing data" were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group. | Posted | Mean | Standard Deviation | units on a scale | baseline (seventh cycle) and at 24 week (twelfth cycle) |
|
from baseline (seventh cycle) to 36 weeks (fifteenth cycle)
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 | MCI-186 - Placebo of MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac 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 |
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 |
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Not provided
|
|
| Placebo of MCI-186 | Drug | Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times. |
|
To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed. |
| baseline (seventh cycle) and at 24 week (twelfth cycle) |
| Percentage of Participants With Adverse Events | 36 weeks (from seventh cycle to fifteenth cycle) |
| Percentage of Participants With Adverse Drug Reactions | 36 weeks (from seventh cycle to fifteenth cycle) |
| Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group | 36 weeks (from seventh cycle to fifteenth cycle) |
| Percentage of Participants With Abnormal Changes in Sensory Examinations | 36 weeks (from seventh cycle to fifteenth cycle) |
| Takahashi F, Takei K, Tsuda K, Palumbo J. Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):32-39. doi: 10.1080/21678421.2017.1361442. |
| Withdrawal by Subject |
|
| Tracheotomy due to worsening of ALS |
|
| Patient's convenience |
|
| MCI-186 - MCI-186 |
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| BG002 | Placebo of MCI-186 - MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection placebo administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| OG001 | MCI-186 - MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion |
| OG002 | Placebo of MCI-186 - MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes 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 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 - Placebo of MCI-186 group. | Posted | Count of Participants | Participants | 24 weeks (from seventh cycle to twelfth cycle) |
|
|
|
| Secondary | Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks | To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed. | "1 patient with diseases other than ALS" and "4 patients with missing data" were excluded from the FAS in the MCI-186 - Placebo of MCI-186group. "6 patients with missing data" were excluded from the FAS in the MCI-186 - MCI-186 group. "19 patients with missing data" were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group. | Posted | Mean | Standard Deviation | percentage of FVC | baseline (seventh cycle) and at 24 week (twelfth cycle) |
|
|
|
| Secondary | Percentage of Participants With Adverse Events | Posted | Number | percentage of participant | 36 weeks (from seventh cycle to fifteenth cycle) |
|
|
|
| Secondary | Percentage of Participants With Adverse Drug Reactions | Posted | Number | percentage of participant | 36 weeks (from seventh cycle to fifteenth cycle) |
|
|
|
| Secondary | Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group | Posted | Number | percentage of participant | 36 weeks (from seventh cycle to fifteenth cycle) |
|
|
|
| Secondary | Percentage of Participants With Abnormal Changes in Sensory Examinations | Posted | Number | percentage of participant | 36 weeks (from seventh cycle to fifteenth cycle) |
|
|
|
| 13 |
| 45 |
| 43 |
| 45 |
| EG001 | MCI-186 - MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion | 25 | 48 | 43 | 48 |
| EG002 | Placebo of MCI-186 - MCI-186 | Cycles 7 to 12 (6 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion Cycles 13 to 15 (3 cycles) : 2 ampoules of edaravone injection 30 mg administered once daily over 60 minutes by intravenous infusion | 39 | 88 | 74 | 88 |
| Retinal vein occlusion | Eye disorders | MedDRA 11.1 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abasia | General disorders | MedDRA 11.1 |
|
| Gait disturbance | General disorders | MedDRA 11.1 |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 |
|
| Bronchopneumonia | Infections and infestations | MedDRA 11.1 |
|
| Catheter site infection | Infections and infestations | MedDRA 11.1 |
|
| Diverticulitis | Infections and infestations | MedDRA 11.1 |
|
| Herpes zoster | Infections and infestations | MedDRA 11.1 |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
|
| Dysarthria | Nervous system disorders | MedDRA 11.1 |
|
| Dyslalia | Nervous system disorders | MedDRA 11.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Respiratory arrest | 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 |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 11.1 |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.1 |
|
| Vertigo | Ear and labyrinth 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 |
|
| Ocular hyperaemia | Eye disorders | MedDRA 11.1 |
|
| Retinal detachment | Eye disorders | MedDRA 11.1 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA 11.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 |
|
| Lip dry | Gastrointestinal disorders | MedDRA 11.1 |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 11.1 |
|
| Loose tooth | Gastrointestinal disorders | MedDRA 11.1 |
|
| Malocclusion | Gastrointestinal disorders | MedDRA 11.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 11.1 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA 11.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 |
|
| Catheter site erythema | General disorders | MedDRA 11.1 |
|
| Chest discomfort | 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 |
|
| Impaired healing | 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 |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 11.1 |
|
| Seasonal allergy | Immune system disorders | MedDRA 11.1 |
|
| Bronchitis | Infections and infestations | MedDRA 11.1 |
|
| Catheter site infection | Infections and infestations | MedDRA 11.1 |
|
| Cystitis | Infections and infestations | MedDRA 11.1 |
|
| Enteritis infectious | Infections and infestations | MedDRA 11.1 |
|
| Enterocolitis viral | Infections and infestations | MedDRA 11.1 |
|
| Folliculitis | Infections and infestations | MedDRA 11.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 |
|
| Infected epidermal cyst | Infections and infestations | MedDRA 11.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 |
|
| Oral herpes | Infections and infestations | MedDRA 11.1 |
|
| Otitis media | Infections and infestations | MedDRA 11.1 |
|
| Periodontal infection | Infections and infestations | MedDRA 11.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 |
|
| Pneumonia | Infections and infestations | MedDRA 11.1 |
|
| Rhinitis | Infections and infestations | MedDRA 11.1 |
|
| Sinobronchitis | Infections and infestations | MedDRA 11.1 |
|
| Sweat gland infection | 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 |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 |
|
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Back injury | 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 |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Fractured coccyx | 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 |
|
| Post gastric surgery syndrome | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 11.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.1 |
|
| Blood potassium increased | Investigations | MedDRA 11.1 |
|
| Blood pressure decreased | 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 |
|
| White blood cell count increased | Investigations | MedDRA 11.1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Monarthritis | 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 |
|
| 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 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.1 |
|
| Headache | Nervous system disorders | MedDRA 11.1 |
|
| Hyposmia | Nervous system disorders | MedDRA 11.1 |
|
| Sciatica | Nervous system disorders | MedDRA 11.1 |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 |
|
| Tension headache | Nervous system disorders | MedDRA 11.1 |
|
| Anxiety | Psychiatric disorders | MedDRA 11.1 |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 11.1 |
|
| Depression | Psychiatric disorders | MedDRA 11.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.1 |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA 11.1 |
|
| Nocturia | Renal and urinary disorders | MedDRA 11.1 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 11.1 |
|
| Urinary retention | Renal and urinary disorders | MedDRA 11.1 |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 11.1 |
|
| Aspiration | 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 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Nasal septum deviation | 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 |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Decubitus ulcer | 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 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Excessive granulation tissue | 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 |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Hypertension | Vascular disorders | MedDRA 11.1 |
|
| Foot fracture | Injury, poisoning and procedural complications | 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 |
|
|
| Urinary glucose |
|
| Title | Measurements |
|---|---|
|
| Vibratory sensation |
|