Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1255-9714 | Other Identifier | WHO (UTN) | |
| 18PTC-R-589358 | Other Grant/Funding Number | Alzheimer's Association | |
| 1R01AG068268-01 | U.S. NIH Grant/Contract | View source |
Not provided
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
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This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.
This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Daily subcutaneous (SC) injection of Low Dose ATH-1017 |
|
| High Dose | Experimental | Daily subcutaneous (SC) injection of High Dose ATH-1017 |
|
| Placebo | Placebo Comparator | Daily subcutaneous (SC) injection of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATH-1017 | Drug | Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-related Potential (ERP) P300 Latency at Baseline | ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1. | At Baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline | The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. It was performed to evaluate the correlation of ERP P300 latency and cognition. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1. |
Not provided
Key Inclusion Criteria:
Age 55 to 85 years
Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
Reliable and capable support person/caregiver
Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:
Key Exclusion Criteria:
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syrentis Clinical Research | Santa Ana | California | 92705 | United States | ||
| Premiere Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21514250 | Background | McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21. |
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This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study comparing ATH-1017 40 milligrams per day (mg/day) and ATH-1017 70 mg/day with placebo in participants with a clinical diagnosis of mild to moderate Alzheimer's disease (AD).
The study was conducted at a total of 6 centers in Australia and 8 centers in the United States (US).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| FG001 | ATH-1017 40 Milligrams (mg) | Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| FG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population: included all randomized participants who received at least one dose of the study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Event-related Potential (ERP) P300 Latency at Baseline | ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1. | Modified Intent-to-Treat (mITT) Population: included all randomized participants who took at least one dose of the study medication and who completed at least one ERP P300 Baseline assessment and/or one post-Baseline ERP P300 assessment. | Posted | Mean | Standard Deviation | Milliseconds (ms) | At Baseline (Day 1) |
|
Up to Week 30
Safety population which included all randomized participants who received at least one dose of the study medication.
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 | Placebo | Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 23.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hans Moebius, CMO | Athira Pharma | 1-866-725-0930 | clinicaltrials@athira.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 | May 25, 2021 | May 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2022 | May 20, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
Not provided
Not provided
Randomized, double-blind, placebo-controlled, parallel-group study
Not provided
Not provided
Not provided
| Placebo | Drug | Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe |
|
| At Baseline (Day 1) |
| West Palm Beach |
| Florida |
| 33407 |
| United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| Neurological Associates of Albany | Albany | New York | 12208 | United States |
| Center for Cognitive Health | Portland | Oregon | 97225 | United States |
| Evergreen Health Research Program | Kirkland | Washington | 98034 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| Central Coast Neurosciences Research | Central Coast | New South Wales | 2261 | Australia |
| St Vincent's Centre for Applied Medical Research, Translational Research Centre | Darlinghurst | New South Wales | 2010 | Australia |
| Hammondcare Greenwich Hospital | Greenwich | New South Wales | 2065 | Australia |
| KaRa MINDS | Macquarie Park | New South Wales | 2113 | Australia |
| HammondCare | Malvern | Victoria | 3144 | Australia |
| Australian Alzheimer's Research Organization | Nedlands | Western Australia | 6009 | Australia |
| BG001 | ATH-1017 40 mg | Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| BG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| OG001 | ATH-1017 40 mg | Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
| OG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 |
|
|
| Secondary | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline | The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. It was performed to evaluate the correlation of ERP P300 latency and cognition. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | At Baseline (Day 1) |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 18 |
| 24 |
| EG001 | ATH-1017 40 mg | Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 | 0 | 27 | 3 | 27 | 24 | 27 |
| EG002 | ATH-1017 70 mg | Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30 | 0 | 26 | 0 | 26 | 26 | 26 |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholinergic syndrome | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site vesicles | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site paraesthesia | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site mass | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Flushing | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hot flush | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Immediate post-injection reaction | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Extensor plantar response | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Cholinergic syndrome | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dysdiadochokinesis | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Dysphemia | Psychiatric disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 23.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Amaurosis fugax | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Genital paraesthesia | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |