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This randomized, double-blind, placebo controlled study will involve 600 healthy (Glucose-6-Phosphate Dehydrogenase [G6PD] normal) volunteers. Participants who meet the eligibility criteria will be randomized (ratio 1:1) to receive a loading dose of either tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit will continue to be assessed for up to 3 more times at approximately 12-week intervals or until resolution or stabilization of the AE whichever is earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafenoquine 200 mg (2 x 100 mg tablets) | Active Comparator | Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks |
|
| Placebo | Placebo Comparator | Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafenoquine | Drug | Tafenoquine 200mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Ophthalmic Safety Event | Number of Participants with One or More protocol-defined serious ophthalmic safety event (SOSE) assessed by retinal changes from baseline using SD-OCT and qFAF. SOSE is assessed by significant retinal changes from baseline using SD-OCT and qFAF. | After 12 months of exposure to study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mean Change From Baseline in Key SD OCT Parameters | Mean change from baseline in key SD OCT parameters including central subfield thickness, total macular volume, and parafoveal (inner ring of Early Treatment Diabetic Retinopathy Study, and retinal thickness. Clinically significant change from baseline for central subfield thickness [change from baseline of at least 40 µm (15% change)]. Clinically significant change from baseline for total macular volume [change of > 10% (0.86 mm3) from baseline]. Clinically significant change from baseline for parafoveal (inner ring) retinal thickness [change from baseline of at least 10 µm]. Clinically significant change from baseline for qFAF (change in mid-ring qFAF unit from baseline of at least 12% in both eyes at the same visit). |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Southern Colorado | Colorado Springs | Colorado | 80909 | United States | ||
| Valley Retina Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34801714 | Derived | Novitt-Moreno A, Martidis A, Gonzalez V, Ransom J, Scott CB, Dow G, Reid M, Smith B, Zottig VE, Read LT, Garver Baldwin LS, Chen FK. Long-term safety of the tafenoquine antimalarial chemoprophylaxis regimen: A 12-month, randomized, double-blind, placebo-controlled trial. Travel Med Infect Dis. 2022 Jan-Feb;45:102211. doi: 10.1016/j.tmaid.2021.102211. Epub 2021 Nov 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tafenoquine 200 mg (2 x 100 mg Tablets) | Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks Tafenoquine: Tafenoquine 200mg |
| FG001 | Placebo | Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tafenoquine 200 mg (2 x 100 mg Tablets) | Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks Tafenoquine: Tafenoquine 200mg |
| BG001 | Placebo |
| 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 | Serious Ophthalmic Safety Event | Number of Participants with One or More protocol-defined serious ophthalmic safety event (SOSE) assessed by retinal changes from baseline using SD-OCT and qFAF. SOSE is assessed by significant retinal changes from baseline using SD-OCT and qFAF. | All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population. | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
Part 1 - Treatment phase (52 weeks) safety follow-up visits at Weeks 4, 12, 24, 52 Part 2 - Follow-up phase (12 weeks) Due to the long half-life of tafenoquine (13-15 days with an expected 65-75-day washout period), all subjects were to return to the clinic at the Week 64 (Visit 7a and 7b) for their EOS visit. Part 3 -If ongoing AE at Week 64., Follow-up Phase (every 12 weeks, up to 12 months after the final dose of IMP)
The collection, evaluation and reporting of AEs/ADRs arising from this clinical study was performed in accordance with the following:
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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 | Tafenoquine 200 mg (2 x 100 mg Tablets) | Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks Tafenoquine: Tafenoquine 200mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrina Riggs | Fast-Track Drugs & Biologics, LLC | 3017622609 | kriggs@fastttrackresearch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2018 | Jul 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C055852 | tafenoquine |
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Identically matched placebo control.
| Placebo |
| Other |
Placebo |
|
| After 12 months of exposure to study drug |
| Number of Participants With Ellipsoid or Interdigitating Zone Disruption | Any ellipsoid or interdigitating zone disruption within the ETDRS grid | After 12 months of exposure to study drug |
| Number of Participants With Mean Change From Baseline in Best Corrected Visual Acuity | Mean change from baseline in BCVA score, the number of participants that have any clinically significant change in ETDRS BCVA (defined as ≥15 letter change [≥ 3 lines] of change in ETDRS BCVA at 4 meters). | After 12 months of exposure to study drug |
| Number of Participants With Corneal Deposits From Slit Lamp Examination of the Corneal Epithelium | Slit lamp examination was use to detect and grade corneal deposits (also known as vortex keratopathy or cornea verticillata) and retinal abnormalities arising from drug-induced phospholipidosis. | After 12 months of exposure to study drug |
| Number of Participants With New Abnormalities Compared With Baseline Observed With Color Retinal Digital Photography | Corneal deposits as determined by digital corneal photographs that are indicative of cornea verticillata also known as vortex keratopathy | After 12 months of exposure to study drug |
| Number of Participants With New Abnormalities Compared With Baseline Observed With Microperimetry | Microperimetry can be a useful tool for objective evaluation of macular function and progression of disease. Macular disease causes impairment of central vision, metamorphopsia, macropsia, micropsia and color vision defect. Microperimetry measures fixation stability which is associated with visual acuity. | After 12 months of exposure to study drug |
| Number of Participants With Any Clinically Significant Change in ETDRS BCVA (Defined as >15 Letter Change [≥ 3 Lines] of Change in ETDRS BCVA at 4 Meters) | Visual acuity was measured in a consistent way in order to detect any changes in vision as described in the Ophthalmic Reference Manual using a set of Early Treatment Diabetic Retinopathy Study (ETDRS) charts and a retro-illuminated box providing standardized illumination. Subjects are seated 4 meters from the letter chart and asked to read the letters. Letters read correctly count towards the total score. In addition, there are 5 letters in each of the 14 lines. The lines are of equal difficulty and follow a logarithmic progression of diminishing letter size related to the minimum angle of resolution. The endpoints include mean change from baseline in BCVA score, the proportion of participants that have any clinically significant change in ETDRS BCVA (defined as ≥15 letter change [≥ 3 lines] of change in ETDRS BCVA at 4 meters). | After 12 months of exposure to study drug |
| Proportion of Participants Who Develop a Color Deficiency Using the Farnsworth-Munsell 100 (FM-100) Hue Test | Color deficiency was assessed using the Farnsworth-Munsell 100 (FM-100) hue test | After 12 months of exposure to study drug |
| Number of Participants Who Develop a Loss of 0.12 or Greater Logarithm of Contrast Sensitivity (logCS) on the Mars Letter Contrast Sensitivity Test | The Mars letter contrast sensitivity test is a set of charts for testing peak visual contrast sensitivity. Subjects are asked to read to letters from left to right across the chart. The logarithm of contrast sensitivity (logCS) score is given by the log contrast sensitivity value at the lowest contrast letter just prior to two incorrectly identified letters, minus a scoring correction. | After 12 months of exposure to study drug |
| Number of Participants Who Develop a Psychiatric Disorder in Accordance With DSM-5 as Assessed With the Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 Assessment Questionnaire | Psychiatric disorders were reported as adverse events | After 12 months of exposure to study drug |
| Number of Participants With an AE of Dizziness or Vertigo and Severity as Assessed by the Dizziness Handicap Inventory | The period of observation for collection of AEs extended from the time of dosing (Day 1, Week 1 [Visit 2]) through the Week 64 follow-up visit. Proportion of participants with an AE of dizziness or vertigo are reported here. | After 12 months of exposure to study drug |
| McAllen |
| Texas |
| 78503 |
| United States |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | One less subject was not included in the safety population due to early withdrawal | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Central Subfield Thickness | One participant excluded due to early withdrawal | Mean | Standard Deviation | um |
|
| Total Macular Volume | One participant excluded due to early withdrawal | Mean | Standard Deviation | mm |
|
| Parafoveal (inner ring) retinal thickness | One participant excluded due to early withdrawal | Mean | Standard Deviation | um |
|
| Parafoveal (outer ring) retinal thickness | One participant excluded due to early withdrawal | Mean | Standard Deviation | um |
|
| Best Corrected Visual Accuity | Best corrected visual accuity at 4m | One participant excluded due to early withdrawal | Mean | Standard Deviation | letters |
|
| OG001 | Placebo | Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks Placebo: Placebo |
|
|
|
| Secondary | Number of Participants With Mean Change From Baseline in Key SD OCT Parameters | Mean change from baseline in key SD OCT parameters including central subfield thickness, total macular volume, and parafoveal (inner ring of Early Treatment Diabetic Retinopathy Study, and retinal thickness. Clinically significant change from baseline for central subfield thickness [change from baseline of at least 40 µm (15% change)]. Clinically significant change from baseline for total macular volume [change of > 10% (0.86 mm3) from baseline]. Clinically significant change from baseline for parafoveal (inner ring) retinal thickness [change from baseline of at least 10 µm]. Clinically significant change from baseline for qFAF (change in mid-ring qFAF unit from baseline of at least 12% in both eyes at the same visit). | All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
|
| Secondary | Number of Participants With Ellipsoid or Interdigitating Zone Disruption | Any ellipsoid or interdigitating zone disruption within the ETDRS grid | All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
|
| Secondary | Number of Participants With Mean Change From Baseline in Best Corrected Visual Acuity | Mean change from baseline in BCVA score, the number of participants that have any clinically significant change in ETDRS BCVA (defined as ≥15 letter change [≥ 3 lines] of change in ETDRS BCVA at 4 meters). | All subjects who received at least 25% of the total planned dose for IMP, had at least one valid baseline and post baseline evaluation by SD-OCT and qFAF, and had no major protocol deviations were included in the Per-Protocol population | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
| Secondary | Number of Participants With Corneal Deposits From Slit Lamp Examination of the Corneal Epithelium | Slit lamp examination was use to detect and grade corneal deposits (also known as vortex keratopathy or cornea verticillata) and retinal abnormalities arising from drug-induced phospholipidosis. | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
| Secondary | Number of Participants With New Abnormalities Compared With Baseline Observed With Color Retinal Digital Photography | Corneal deposits as determined by digital corneal photographs that are indicative of cornea verticillata also known as vortex keratopathy | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
| Secondary | Number of Participants With New Abnormalities Compared With Baseline Observed With Microperimetry | Microperimetry can be a useful tool for objective evaluation of macular function and progression of disease. Macular disease causes impairment of central vision, metamorphopsia, macropsia, micropsia and color vision defect. Microperimetry measures fixation stability which is associated with visual acuity. | Per protocol subjects | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
|
| Secondary | Number of Participants With Any Clinically Significant Change in ETDRS BCVA (Defined as >15 Letter Change [≥ 3 Lines] of Change in ETDRS BCVA at 4 Meters) | Visual acuity was measured in a consistent way in order to detect any changes in vision as described in the Ophthalmic Reference Manual using a set of Early Treatment Diabetic Retinopathy Study (ETDRS) charts and a retro-illuminated box providing standardized illumination. Subjects are seated 4 meters from the letter chart and asked to read the letters. Letters read correctly count towards the total score. In addition, there are 5 letters in each of the 14 lines. The lines are of equal difficulty and follow a logarithmic progression of diminishing letter size related to the minimum angle of resolution. The endpoints include mean change from baseline in BCVA score, the proportion of participants that have any clinically significant change in ETDRS BCVA (defined as ≥15 letter change [≥ 3 lines] of change in ETDRS BCVA at 4 meters). | Per protocol subjects | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
| Secondary | Proportion of Participants Who Develop a Color Deficiency Using the Farnsworth-Munsell 100 (FM-100) Hue Test | Color deficiency was assessed using the Farnsworth-Munsell 100 (FM-100) hue test | Per protocol subjects | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
| Secondary | Number of Participants Who Develop a Loss of 0.12 or Greater Logarithm of Contrast Sensitivity (logCS) on the Mars Letter Contrast Sensitivity Test | The Mars letter contrast sensitivity test is a set of charts for testing peak visual contrast sensitivity. Subjects are asked to read to letters from left to right across the chart. The logarithm of contrast sensitivity (logCS) score is given by the log contrast sensitivity value at the lowest contrast letter just prior to two incorrectly identified letters, minus a scoring correction. | Per protocol subjects | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
|
| Secondary | Number of Participants Who Develop a Psychiatric Disorder in Accordance With DSM-5 as Assessed With the Mini International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 Assessment Questionnaire | Psychiatric disorders were reported as adverse events | Safety population | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
|
| Secondary | Number of Participants With an AE of Dizziness or Vertigo and Severity as Assessed by the Dizziness Handicap Inventory | The period of observation for collection of AEs extended from the time of dosing (Day 1, Week 1 [Visit 2]) through the Week 64 follow-up visit. Proportion of participants with an AE of dizziness or vertigo are reported here. | Safety population | Posted | Count of Participants | Participants | After 12 months of exposure to study drug |
|
|
|
|
| 0 |
| 301 |
| 23 |
| 301 |
| 274 |
| 301 |
| EG001 | Placebo | Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks Placebo: Placebo | 0 | 299 | 17 | 299 | 268 | 299 |
| Myocardial Ischaemia | Cardiac disorders | Non-systematic Assessment |
|
| Hypospadias | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | Non-systematic Assessment |
|
| Anorectal Disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Otitis Media | Infections and infestations | Non-systematic Assessment |
|
| Periorbital Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pyelonephritis Acute | Infections and infestations | Non-systematic Assessment |
|
| Viral Pericarditis | Infections and infestations | Non-systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament Rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Meniscus Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Weight Increased | Investigations | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Adjustment Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Major Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Cervical Dysplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Testicular Torsion | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abortion Induced | Surgical and medical procedures | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Haemolysis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Methaemoglobinaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Atrioventricular Block First Degree | Cardiac disorders | Non-systematic Assessment |
|
| Atrioventricular Dissociation | Cardiac disorders | Non-systematic Assessment |
|
| Mitral Valve Incompetence | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Hypospadias | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Eustachian Tube Dysfunction | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Motion Sickness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Vertigo Positional | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | Non-systematic Assessment |
|
| Hypopituitarism | Endocrine disorders | Non-systematic Assessment |
|
| Thyroid Mass | Endocrine disorders | Non-systematic Assessment |
|
| Acute Macular Outer Retinopathy | Eye disorders | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | Non-systematic Assessment |
|
| Cataract Cortical | Eye disorders | Non-systematic Assessment |
|
| Chalazion | Eye disorders | Non-systematic Assessment |
|
| Conjunctival Haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Conjunctival Hyperaemia | Eye disorders | Non-systematic Assessment |
|
| Conjunctivitis Allergic | Eye disorders | Non-systematic Assessment |
|
| Cornea Opacity | Eye disorders | Non-systematic Assessment |
|
| Cornea Verticillata | Eye disorders | Non-systematic Assessment |
|
| Cornea Verticillata (grade 2 or greater) | Eye disorders | Non-systematic Assessment |
|
| Corneal Deposits | Eye disorders | Non-systematic Assessment |
|
| Corneal Erosion | Eye disorders | Non-systematic Assessment |
|
| Corneal Opacity | Eye disorders | Non-systematic Assessment |
|
| Corneal Scar | Eye disorders | Non-systematic Assessment |
|
| Deposit Eye | Eye disorders | Non-systematic Assessment |
|
| Diplopia | Eye disorders | Non-systematic Assessment |
|
| Dry Eye | Eye disorders | Non-systematic Assessment |
|
| Eczema Eyelids | Eye disorders | Non-systematic Assessment |
|
| Eye Irritation | Eye disorders | Non-systematic Assessment |
|
| Eye Pain | Eye disorders | Non-systematic Assessment |
|
| Eye Pruritus | Eye disorders | Non-systematic Assessment |
|
| Eyelids Pruritus | Eye disorders | Non-systematic Assessment |
|
| Foreign Body Sensation in Eyes | Eye disorders | Non-systematic Assessment |
|
| Hypermetropia | Eye disorders | Non-systematic Assessment |
|
| Iris Cyst | Eye disorders | Non-systematic Assessment |
|
| Keratic Precipitates | Eye disorders | Non-systematic Assessment |
|
| Lacrimation Increased | Eye disorders | Non-systematic Assessment |
|
| Lenticular Opacities | Eye disorders | Non-systematic Assessment |
|
| Loss of Visual Contrast Sensitivity | Eye disorders | Non-systematic Assessment |
|
| Macular Cyst | Eye disorders | Non-systematic Assessment |
|
| Meibomian Gland Dysfunction | Eye disorders | Non-systematic Assessment |
|
| Metamorphopsia | Eye disorders | Non-systematic Assessment |
|
| Night Blindness | Eye disorders | Non-systematic Assessment |
|
| Ocular Hyperaemia | Eye disorders | Non-systematic Assessment |
|
| Optic Disc Haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Periorbital Oedema | Eye disorders | Non-systematic Assessment |
|
| Photokeratitis | Eye disorders | Non-systematic Assessment |
|
| Photophobia | Eye disorders | Non-systematic Assessment |
|
| Pinguecula | Eye disorders | Non-systematic Assessment |
|
| Presbyopia | Eye disorders | Non-systematic Assessment |
|
| Pterygium | Eye disorders | Non-systematic Assessment |
|
| Punctate Keratitis | Eye disorders | Non-systematic Assessment |
|
| Retinal Cyst | Eye disorders | Non-systematic Assessment |
|
| Retinal Degeneration | Eye disorders | Non-systematic Assessment |
|
| Retinal Deposits | Eye disorders | Non-systematic Assessment |
|
| Retinal Disorder | Eye disorders | Non-systematic Assessment |
|
| Retinal Exudates | Eye disorders | Non-systematic Assessment |
|
| Retinal Haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | Non-systematic Assessment |
|
| Visual Impairment | Eye disorders | Non-systematic Assessment |
|
| Vitreous Detachment | Eye disorders | Non-systematic Assessment |
|
| Vitreous Floaters | Eye disorders | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Tenderness | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anorectal Disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Aphthous Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Faeces Discoloured | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal Disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gingival Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
|
| Malpositioned Teeth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oral Mucosal Blistering | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | Non-systematic Assessment |
|
| Paraesthesia Oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tooth Impacted | Gastrointestinal disorders | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Adverse Drug Reaction | General disorders | Non-systematic Assessment |
|
| Adverse Food Reaction | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Complication Associated With Device | General disorders | Non-systematic Assessment |
|
| Cyst | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Hangover | General disorders | Non-systematic Assessment |
|
| Inflammation | General disorders | Non-systematic Assessment |
|
| Influenza Like Illness | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Medical Device Pain | General disorders | Non-systematic Assessment |
|
| Medical Device Site Injury | General disorders | Non-systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Peripheral Swelling | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Sensation of Foreign Body | General disorders | Non-systematic Assessment |
|
| Vessel Puncture Site Haematoma | General disorders | Non-systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | Non-systematic Assessment |
|
| Allergy to Animal | Immune system disorders | Non-systematic Assessment |
|
| Allergy to Arthropod Sting | Immune system disorders | Non-systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | Non-systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | Non-systematic Assessment |
|
| Abscess of External Auditory Meatus | Infections and infestations | Non-systematic Assessment |
|
| Acute Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Alveolar Osteitis | Infections and infestations | Non-systematic Assessment |
|
| Bacterial Infection | Infections and infestations | Non-systematic Assessment |
|
| Bacterial Vaginosis | Infections and infestations | Non-systematic Assessment |
|
| Blastocystis Infection | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Chlamydial Infection | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis Viral | Infections and infestations | Non-systematic Assessment |
|
| Covid-19 | Infections and infestations | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | Non-systematic Assessment |
|
| Enterobiasis | Infections and infestations | Non-systematic Assessment |
|
| External Ear Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | Non-systematic Assessment |
|
| Fungal Skin Infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | Non-systematic Assessment |
|
| Gonorrhoea | Infections and infestations | Non-systematic Assessment |
|
| Herpes Simplex | Infections and infestations | Non-systematic Assessment |
|
| Herpes Virus Infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | Non-systematic Assessment |
|
| Infectious Mononucleosis | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Localised Infection | Infections and infestations | Non-systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Molluscum Contagiosum | Infections and infestations | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | Non-systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Oral Herpes | Infections and infestations | Non-systematic Assessment |
|
| Otitis Externa | Infections and infestations | Non-systematic Assessment |
|
| Otitis Media | Infections and infestations | Non-systematic Assessment |
|
| Otitis Media Acute | Infections and infestations | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | Non-systematic Assessment |
|
| Pericoronitis | Infections and infestations | Non-systematic Assessment |
|
| Periorbital Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Post Procedural Infection | Infections and infestations | Non-systematic Assessment |
|
| Pyelonephritis Acute | Infections and infestations | Non-systematic Assessment |
|
| Respiratory Tract Infection Viral | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis Bacterial | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcal Skin Infection | Infections and infestations | Non-systematic Assessment |
|
| Tinea Pedis | Infections and infestations | Non-systematic Assessment |
|
| Tinea Versicolour | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Tooth Abscess | Infections and infestations | Non-systematic Assessment |
|
| Tooth Infection | Infections and infestations | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection Bacterial | Infections and infestations | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | Non-systematic Assessment |
|
| Viral Pericarditis | Infections and infestations | Non-systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Vulvovaginal Candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Adverse Event Following Immunisation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Animal Scratch | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arthropod Sting | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Back Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Burns Second Degree | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Chemical Eye Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Corneal Abrasion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Eye Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Eye Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fibula Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Foreign Body In Eye | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fractured Coccyx | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hand Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Heat Exhaustion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Heat Stroke | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint Dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament Rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Meniscus Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nail Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Neck Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nerve Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post Procedural Complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post-Traumatic Neck Syndrome | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post-Traumatic Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Repetitive Strain Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin Abrasion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Soft Tissue Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Tendon Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Traumatic Haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vaccination Complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Venomous Sting | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Non-systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | Non-systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | Non-systematic Assessment |
|
| Blood Pressure Diastolic Increased | Investigations | Non-systematic Assessment |
|
| Blood Pressure Increased | Investigations | Non-systematic Assessment |
|
| Blood Pressure Systolic Increased | Investigations | Non-systematic Assessment |
|
| Blood Testosterone Decreased | Investigations | Non-systematic Assessment |
|
| Carbohydrate Tolerance Analyses (Incl Diabetes) | Investigations | Non-systematic Assessment |
|
| Colour Vision Tests Abnormal | Investigations | Non-systematic Assessment |
|
| Electrocardiogram PR Prolongation | Investigations | Non-systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Investigations | Non-systematic Assessment |
|
| Glomerular Filtration Rate Decreased | Investigations | Non-systematic Assessment |
|
| Heart Rate Irregular | Investigations | Non-systematic Assessment |
|
| Sars-Cov-2 Test Positive | Investigations | Non-systematic Assessment |
|
| Urine Analysis Abnormal | Investigations | Non-systematic Assessment |
|
| Vascular Tests NEC (Incl Blood Pressure) | Investigations | Non-systematic Assessment |
|
| Visual Acuity Tests Abnormal | Investigations | Non-systematic Assessment |
|
| Visual Field Tests Abnormal | Investigations | Non-systematic Assessment |
|
| Weight Increased | Investigations | Non-systematic Assessment |
|
| White Blood Cells Urine | Investigations | Non-systematic Assessment |
|
| Alcohol Intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Iron Deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Vitamin B12 Deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Fatigue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Plantar Fasciitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Synovial Cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | Non-systematic Assessment |
|
| Balance Disorder | Nervous system disorders | Non-systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Cervicogenic Headache | Nervous system disorders | Non-systematic Assessment |
|
| Disturbance In Attention | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness Postural | Nervous system disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Facial Paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | Non-systematic Assessment |
|
| Idiopathic Intracranial Hypertension | Nervous system disorders | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
|
| Lumbar Radiculopathy | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Migraine With Aura | Nervous system disorders | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | Non-systematic Assessment |
|
| Nystagmus | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Parosmia | Nervous system disorders | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | Non-systematic Assessment |
|
| Psychomotor Hyperactivity | Nervous system disorders | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | Non-systematic Assessment |
|
| Sinus Headache | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Tension Headache | Nervous system disorders | Non-systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Pregnancy | Nervous system disorders | Non-systematic Assessment |
|
| Abnormal Dreams | Psychiatric disorders | Non-systematic Assessment |
|
| Adjustment Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Affect Lability | Psychiatric disorders | Non-systematic Assessment |
|
| Alcohol Use Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Panic Attack | Psychiatric disorders | Non-systematic Assessment |
|
| Panic Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Generalised Anxiety Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Social Anxiety Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Binge Eating | Psychiatric disorders | Non-systematic Assessment |
|
| Bulimia Nervosa | Psychiatric disorders | Non-systematic Assessment |
|
| Bulimia Nervosa | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Depressive Symptom | Psychiatric disorders | Non-systematic Assessment |
|
| Major Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Mood Altered | Psychiatric disorders | Non-systematic Assessment |
|
| Mood Swings | Psychiatric disorders | Non-systematic Assessment |
|
| Persistent Depressive Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Post-Traumatic Stress Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | Non-systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | Non-systematic Assessment |
|
| Genito-Pelvic Pain/Penetration Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Hypervigilance | Psychiatric disorders | Non-systematic Assessment |
|
| Initial Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | Non-systematic Assessment |
|
| Obsessive-Compulsive Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | Non-systematic Assessment |
|
| Suicidal Behaviour | Psychiatric disorders | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Tract Disorder | Renal and urinary disorders | Non-systematic Assessment |
|
| Urine Abnormality | Renal and urinary disorders | Non-systematic Assessment |
|
| Breast Cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Cervical Dysplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dysfunctional Uterine Bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Genital Hyperaesthesia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Menstruation Irregular | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Oligomenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Testicular Torsion | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vaginal Discharge | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vulval Disorder | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dry Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Irregular Breathing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pharyngeal Ulceration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper-Airway Cough Syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hand Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hidradenitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ingrowing Nail | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ingrown Hair | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash Macular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Sebaceous Gland Disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin Reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Abortion Induced | Surgical and medical procedures | Non-systematic Assessment |
|
| Artificial Crown Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
| Dental Implantation | Surgical and medical procedures | Non-systematic Assessment |
|
| Lip Operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Tooth Extraction | Surgical and medical procedures | Non-systematic Assessment |
|
| Wisdom Teeth Removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Hot Flush | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Number of Subjects with Clinically Significant Change in Parafoveal (inner ring) Retinal Thickness |
|
| Number of Subjects with Clinically Significant Change in Mid Ring qFAF Patterns |
|
| Fisher Exact |
| 0.12 |
| Superiority |
| Number of Subjects with Clinically Significant Change in Parafoveal (inner ring) Retinal Thickness | Fisher Exact | 0.84 | Superiority |
| Number of Subjects with Clinically Significant Change in Mid Ring qFAF Patterns | Fisher Exact | 0.65 | Superiority |