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The purpose of this study is to determine whether orally administered DS107 (1g and 2g doses) is effective in the treatment of moderate to severe atopic dermatitis.
Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.
The study will enroll approximately 300 subjects.
The study will consist of 3 treatment arms, each consisting of approximately 100 subjects.
Treatment Arm 1 will receive 1g Oral DS107 daily. Treatment Arm 2 will receive 2g Oral DS107 daily. Treatment Arm 3 will receive placebo daily.
The primary objective of the study is to assess the efficacy and safety of daily 1g and 2g doses of Oral DS107 versus placebo.
Subjects will come to the clinic on 7 occasions: Screening, Baseline, Week 2, Week 4, Week 6, Week 8 (end of treatment/early termination) and Week 10 (follow-up). The primary efficacy variable will be the IGA (Investigator's Global Assessment). Secondary efficacy variables will include IGA, EASI (Eczema Area and Severity Index), and NRS (Numeric Rating Scale),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1g DS107 | Experimental | 1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks. |
|
| 2g DS107 | Experimental | 2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks. |
|
| Placebo | Placebo Comparator | Placebo (4 placebo capsules) orally administered once-daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS107 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving an Investigators Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population at Week 8. | Proportion of patients achieving an IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population at Week 8. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10. | Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Weissbach, Ph.D | DS Biopharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DS Biopharma Site | Philadelphia | Pennsylvania | United States | |||
| DS Biopharma Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25907057 | Background | Amagai Y, Oida K, Matsuda A, Jung K, Kakutani S, Tanaka T, Matsuda K, Jang H, Ahn G, Xia Y, Kawashima H, Shibata H, Matsuda H, Tanaka A. Dihomo-gamma-linolenic acid prevents the development of atopic dermatitis through prostaglandin D1 production in NC/Tnd mice. J Dermatol Sci. 2015 Jul;79(1):30-7. doi: 10.1016/j.jdermsci.2015.03.010. Epub 2015 Apr 6. | |
| 15731121 |
Not provided
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Eligible patients were randomized (1:1:1) to receive 1 g DS107, 2 g DS107, or placebo administered orally once daily for 8 weeks.
Approximately 300 patients (100 per treatment group) with moderate to severe Atopic Dermatitis (AD) were to be included in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1g DS107 | 1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks. |
| FG001 | 2g DS107 | 2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks. |
| FG002 | Placebo | Placebo (4 placebo capsules) orally administered once-daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received. Demographic information used for Baseline characteristics was reported on using the Full Analysis (n=311) and Safety Analysis total was used for Participant flow (n=321).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group A | 1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks. |
| BG001 | Treatment Group B | 2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks. |
| 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 | Proportion of Patients Achieving an Investigators Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population at Week 8. | Proportion of patients achieving an IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population at Week 8. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. | The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received. | Posted | Number | Proportion of participants | 8 weeks |
|
10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
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 | 1g DS107 | 1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip Arthroplasty | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | DS Biopharma | +353 1 2933590 | regulatory.dsbiopharma@DSBiopharma.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 | Jul 14, 2017 | Aug 2, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2017 | Aug 2, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| Baseline, Week 2, Week 4, Week 6 and Week 10 |
| Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10 | Proportion of patients achieving a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, 8, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
| Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10 | Change from Baseline in EASI in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. It quantifies the severity of a patient's AD based on both lesion severity and the percent of Body Surface Area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The subscales used are summed in order to give a final EASI score. A decrease in EASI score represents a positive outcome for the patient. | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
| Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10 | Change from Baseline in Numeric Rating Scale (NRS) for pruritus in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. Severity of pruritus related to AD will be self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale at screening and then daily starting at baseline through to the last study visit. A decrease in NRS represents a positive outcome for the patient. | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
| Cape Town |
| South Africa |
| Ashcroft DM, Dimmock P, Garside R, Stein K, Williams HC. Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials. BMJ. 2005 Mar 5;330(7490):516. doi: 10.1136/bmj.38376.439653.D3. Epub 2005 Feb 24. |
| 7910330 | Background | Bos JD, Kapsenberg ML, Smitt JH. Pathogenesis of atopic eczema. Lancet. 1994 May 28;343(8909):1338-41. doi: 10.1016/s0140-6736(94)92473-2. No abstract available. |
| 15611432 | Background | Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004 Dec;140(12):1513-9. doi: 10.1001/archderm.140.12.1513. |
| 24232668 | Background | Desbois AP, Lawlor KC. Antibacterial activity of long-chain polyunsaturated fatty acids against Propionibacterium acnes and Staphylococcus aureus. Mar Drugs. 2013 Nov 13;11(11):4544-57. doi: 10.3390/md11114544. |
| 24138436 | Background | Carpenter JR, Roger JH, Kenward MG. Analysis of longitudinal trials with protocol deviation: a framework for relevant, accessible assumptions, and inference via multiple imputation. J Biopharm Stat. 2013;23(6):1352-71. doi: 10.1080/10543406.2013.834911. |
| 16815157 | Background | Williams H, Flohr C. How epidemiology has challenged 3 prevailing concepts about atopic dermatitis. J Allergy Clin Immunol. 2006 Jul;118(1):209-13. doi: 10.1016/j.jaci.2006.04.043. Epub 2006 Jun 9. |
| 17985168 | Background | Kawashima H, Tateishi N, Shiraishi A, Teraoka N, Tanaka T, Tanaka A, Matsuda H, Kiso Y. Oral administration of dihomo-gamma-linolenic acid prevents development of atopic dermatitis in NC/Nga mice. Lipids. 2008 Jan;43(1):37-43. doi: 10.1007/s11745-007-3129-2. Epub 2007 Nov 6. |
| 24094544 | Background | Silverberg JI, Hanifin JM. Adult eczema prevalence and associations with asthma and other health and demographic factors: a US population-based study. J Allergy Clin Immunol. 2013 Nov;132(5):1132-8. doi: 10.1016/j.jaci.2013.08.031. Epub 2013 Oct 4. |
| 20070141 | Background | Simpson EL. Atopic dermatitis: a review of topical treatment options. Curr Med Res Opin. 2010 Mar;26(3):633-40. doi: 10.1185/03007990903512156. |
| 22101513 | Background | Suarez AL, Feramisco JD, Koo J, Steinhoff M. Psychoneuroimmunology of psychological stress and atopic dermatitis: pathophysiologic and therapeutic updates. Acta Derm Venereol. 2012 Jan;92(1):7-15. doi: 10.2340/00015555-1188. |
| 8457021 | Background | Kapp A. The role of eosinophils in the pathogenesis of atopic dermatitis--eosinophil granule proteins as markers of disease activity. Allergy. 1993 Jan;48(1):1-5. doi: 10.1111/j.1398-9995.1993.tb02167.x. |
| 12531593 | Background | Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003 Jan 11;361(9352):151-60. doi: 10.1016/S0140-6736(03)12193-9. |
| 24813302 | Background | Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9. |
| 24278069 | Background | Gutfreund K, Bienias W, Szewczyk A, Kaszuba A. Topical calcineurin inhibitors in dermatology. Part I: Properties, method and effectiveness of drug use. Postepy Dermatol Alergol. 2013 Jun;30(3):165-9. doi: 10.5114/pdia.2013.35619. Epub 2013 Jun 20. |
| 11438134 | Background | Reynolds NJ, Franklin V, Gray JC, Diffey BL, Farr PM. Narrow-band ultraviolet B and broad-band ultraviolet A phototherapy in adult atopic eczema: a randomised controlled trial. Lancet. 2001 Jun 23;357(9273):2012-6. doi: 10.1016/S0140-6736(00)05114-X. |
| 1329675 | Background | Iversen L, Fogh K, Kragballe K. Effect of dihomogammalinolenic acid and its 15-lipoxygenase metabolite on eicosanoid metabolism by human mononuclear leukocytes in vitro: selective inhibition of the 5-lipoxygenase pathway. Arch Dermatol Res. 1992;284(4):222-6. doi: 10.1007/BF00375798. |
| 19275928 | Background | Kawashima H, Toyoda-Ono Y, Suwa Y, Kiso Y. Subchronic (13-week) oral toxicity study of dihomo-gamma-linolenic acid (DGLA) oil in rats. Food Chem Toxicol. 2009 Jun;47(6):1280-6. doi: 10.1016/j.fct.2009.03.001. Epub 2009 Mar 9. |
| 26685719 | Background | Futamura M, Leshem YA, Thomas KS, Nankervis H, Williams HC, Simpson EL. A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards. J Am Acad Dermatol. 2016 Feb;74(2):288-94. doi: 10.1016/j.jaad.2015.09.062. Epub 2015 Dec 11. |
| 11168575 | Background | Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x. |
| 22170091 | Background | Phan NQ, Blome C, Fritz F, Gerss J, Reich A, Ebata T, Augustin M, Szepietowski JC, Stander S. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012 Sep;92(5):502-7. doi: 10.2340/00015555-1246. |
| Investigator Discretion |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Other - Subject discontinued following database lock. |
|
| Other - Subject underwent knee surgery and stopped taking study medication. |
|
| Subject moved out of the country. |
|
| BG002 | Treatment Group C | Placebo (4 placebo capsules) orally administered once-daily for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| 1g DS107 |
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks. |
| OG001 | 2g DS107 | 2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks. |
| OG002 | Placebo | Placebo (4 placebo capsules) orally administered once-daily for 8 weeks. |
|
|
|
| Secondary | Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10. | Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. | The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received. | Posted | Number | Proportion of participants | Baseline, Week 2, Week 4, Week 6 and Week 10 |
|
|
|
| Secondary | Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10 | Proportion of patients achieving a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, 8, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. | The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received. | Posted | Number | Proportion of participants | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
|
|
|
| Secondary | Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10 | Change from Baseline in EASI in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. It quantifies the severity of a patient's AD based on both lesion severity and the percent of Body Surface Area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The subscales used are summed in order to give a final EASI score. A decrease in EASI score represents a positive outcome for the patient. | The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received. | Posted | Mean | Standard Deviation | EASI Index | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
|
|
|
| Secondary | Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10 | Change from Baseline in Numeric Rating Scale (NRS) for pruritus in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. Severity of pruritus related to AD will be self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale at screening and then daily starting at baseline through to the last study visit. A decrease in NRS represents a positive outcome for the patient. | The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
|
|
|
| 0 |
| 105 |
| 1 |
| 105 |
| 34 |
| 105 |
| EG001 | 2g DS107 | 2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks. | 0 | 112 | 1 | 112 | 42 | 112 |
| EG002 | Placebo | Placebo (4 placebo capsules) orally administered once-daily for 8 weeks. | 0 | 104 | 0 | 104 | 34 | 104 |
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Eye pruritus | Eye disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Oedema Peripheral | General disorders | Systematic Assessment |
|
| Vessel Puncture Site Bruise | General disorders | Systematic Assessment |
|
| Food Allegry | Immune system disorders | Systematic Assessment |
|
| Breast Abscess | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | Systematic Assessment |
|
| Eczema Infected | Infections and infestations | Systematic Assessment |
|
| Furuncle | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Subcutaneous Abscess | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Viral Rash | Infections and infestations | Systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Vulvovaginal Mycotic Infection | Infections and infestations | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine Aminotransferase Abnormal | Investigations | Systematic Assessment |
|
| Aspartate Aminotransferase Abnormal | Investigations | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Bacterial Test Positive | Investigations | Systematic Assessment |
|
| Blood Creatine Phosphokinase | Investigations | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | Systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Investigations | Systematic Assessment |
|
| Blood Triglycerides Increased | Investigations | Systematic Assessment |
|
| Blood Uric Acid Increased | Investigations | Systematic Assessment |
|
| Crystal Urine | Investigations | Systematic Assessment |
|
| Protein Urine | Investigations | Systematic Assessment |
|
| Urinary Sediment Present | Investigations | Systematic Assessment |
|
| Urine Uric Acid | Investigations | Systematic Assessment |
|
| White Blood Cells Urine Positive | Investigations | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Calculus Urinary | Renal and urinary disorders | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Breast Tenderness | Reproductive system and breast disorders | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
|
| Uterine Haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis Allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Breast Conserving Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Week 6 |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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